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1.  Blood donations from previously transfused or pregnant donors: a multicenter study to determine the frequency of alloexposure 
Transfusion  2010;51(6):1197-1206.
Transfusion-related acute lung injury (TRALI) mitigation strategies include the deferral of female donors from apheresis platelet (PLT) donations and the distribution of plasma for transfusion from male donors only. We studied the implications of these policies in terms of component loss at six blood centers in the United States.
We collected data from allogeneic blood donors making whole blood and blood component donations during calendar years 2006 through 2008. We analyzed the distribution of donations in terms of the sex, transfusion and pregnancy histories, and blood type.
A TRALI mitigation policy that would not allow plasma from female whole blood donors to be prepared into transfusable plasma components would result in nearly a 50% reduction in the units of whole blood available for plasma manufacturing and would decrease the number of type AB plasma units that could be made from whole blood donations by the same amount. Deferral of all female apheresis PLT donors, all female apheresis PLT donors with histories of prior pregnancies, or all female apheresis PLT donors with histories of prior pregnancies and positive screening test results for antibodies to human leukocyte antigens (HLAs) will result in a loss of 37.1, 22.5, and 5.4% of all apheresis PLT donations, respectively.
A TRALI mitigation policy that only defers female apheresis PLT donors with previous pregnancies and HLAs would result in an approximately 5% decrease in the inventory of apheresis PLTs, but would eliminate a large proportion of components that are associated with TRALI.
PMCID: PMC3606016  PMID: 21182532
2.  Demographic Characteristics and Prevalence of Serologic Markers among Blood Donors Who Use Confidential Unit Exclusion (CUE) in São Paulo, Brazil: Implications for Modification of CUE Polices in Brazil 
Transfusion  2011;51(1):191-197.
This study evaluated demographic profiles and prevalence of serologic markers of donors who used CUE in order to assess the effectiveness of CUE and guide public policies regarding the use of CUE for enhancing safety versus jeopardizing the blood supply by dropping CUE.
Material and Methods
We conducted a cross-sectional analysis of whole blood donations at a large public blood center in São Paulo from July 2007 through June 2009, and compared demographic data and confirmed serologic results among donors who used and who have never used CUE (CUE never).
There were 265,550 whole blood units collected from 181,418 donors from July 2007 through June 2009. A total of 9,659 (3.6%) units were discarded, 2,973 (1.1%) because CUE was used at the current donation (CUE now) and 6,685 (2.5%) because CUE was used in the past (CUE past). The CUE rate was highest among donors with less than 8 years of education (OR=2.78; CI = 2.51–3.08). CUE now donations were associated with higher positive infectious disease marker rates than CUE never donations (OR= 1.41; CI = 1.13–1.77), whereas CUE past donations were not (OR=1.04; CI = 0.75–1.45).
The CUE process results in a high rate of unit discard. CUE use on an individual donation appears predictive of a high risk marker positive donation and, thus appears to contribute modestly to blood safety. The policy of discarding units from donors, who have previously CUE positive donations, does not improve safety and should be discontinued.
PMCID: PMC3170091  PMID: 20663108
HIV; blood donors; Brazil; donor selection; risk reduction behavior
3.  Four phases of checks for exclusion of umbilical cord blood donors 
Blood Transfusion  2011;9(3):286-291.
The aim of this study was to analyse umbilical cord blood (UCB) collection over 1 year between October 2008 and September 2009, seeking ways to improve the number of suitable banked UCB units. Four phases of the process were investigated, from the consent form to the banking procedure, paying attention to the discarded UCB units.
Material and methods
We recruited couples at 35 weeks of gestation and took an accurate history, focusing on genetic, immunological and infectious diseases. We collected UCB from pregnant women who delivered vaginally or by Caesarean section between the 37–41+6 weeks of gestation. Some units were discarded on the basis of the patients' history, obstetric events or biological criteria. In utero collection was the preferred method of collection.
During the study period, between October 2008 and September 2009, there were 1,477 deliveries in our unit. The number of couples interested in UCB donation was 595 (40.2%-595/1,477). We collected 393 UBC units. We excluded 122 patients at the phase of the history taking, counselling and informed consent (first phase check). Of the 393 units collected, 162 (41.3%) were banked whereas 231 (58.7%) were discarded because they did not fulfil biological criteria (third phase check). The volume of UCB units collected after Caesarean section was greater than the volume of units collected after vaginal delivery (95.4 mL versus 85.0 mL, respectively; p <0.01). The UCB units collected after vaginal delivery contained a higher number of total nucleated cells compared to the units collected after Caesarean section (970x106 cells versus 874x106 cells, respectively; p=0.037). None of the banked UCB units was discarded at the clinical check 6 months after delivery (fourth phase check).
Our study shows that strict observance of each of the checks and the collection strategy is important to guarantee the safety of the UCB units and to maximise the cost-benefit ratio. After the appropriate checks we banked UCB units from only 27.2% (162/595) of the couples who gave consent to the procedure and from only 11% (162/1,477) of all the deliveries in the 12 month study period, as 59.8% of couples were not properly informed about UCB donation.
PMCID: PMC3136596  PMID: 21627927
cord blood; obstetric factors; stem cells
4.  Cost effectiveness of Iran national plasma contract fractionation program 
Plasma derived medicines (PDM) including immunoglobulins, clotting factors and albumin are life saving medicines which due to their high costs are inaccessible for many patients living in developing countries. By contrary substantial volume of plasma as raw materials for production of these medicines are discarded worldwide. Good quality recovered plasma, as a result of separation of donated blood into its components, could be used for production of PDM. In 2011 Iranian donors donated about 2 million units of blood. A shift from administration of whole blood to components therapy has resulted in the generation of over 250,000 liters of surplus of recovered plasma. This created a good opportunity for Iran’s health care system to use this plasma for production of PDM. Therefore Iran national transfusion service has started a contract fractionation program for converting recovered plasma into PDM. This program not only provided essential PDM for Iran pharmaceutical market but also has created a direct saving of about 8.5 million Euros in 2011 for national health sector. In addition this program has drastically contributed to improvement of overall quality of working procedures and services provided by Iran national blood transfusion organization.
PMCID: PMC3556006  PMID: 23351278
Iran; Cost effectiveness; Plasma contract fractionation; Blood transfusion service
5.  Evaluation of DNA extraction from granulocytes discarded in the separation medium after isolation of peripheral blood mononuclear cells and plasma from whole blood 
BMC Research Notes  2013;6:440.
Whole blood is generally processed for plasma and peripheral blood mononuclear cells (PBMCs) from granulocytes/erythrocytes using gradient centrifugation of blood with Histopaue-Ficoll. After separation of plasma and PBMCs, the residual erythrocytes/granulocytes, a rich source of DNA, is often discarded along with the separation medium. In order to isolate DNA from the granulocytes, current methods require the removal of the separation medium and subsequent purification of granulocytes. This report provides a method for extracting DNA using the PAXgene Blood DNA kit from granulocytes without purifying them from the separation medium.
Based on 719 erythrocyte/granulocyte samples stored frozen for approximately 10 years in Ficoll-Hypaque separation medium, the mean yield of DNA was 395 μg (median = 281 μg; range = 1.36 to 2077.2 μg), with mean A260/A280 ratio of 1.84 (median = 1.84; range = 1.17 to 2.23). The quality of isolated DNA was sufficient for use as a template for restriction enzyme digestion, real-time PCR, pyrosequencing, and gel based variable number tandem repeats (VNTR) genotyping.
By demonstrating the extraction of substantial amounts of high quality granulocytes DNA without purifying them from the separation medium, this method offers laboratories and biobanks a flexible and cost-effective approach to obtain plasma, PBMCs, and large amounts of DNA from a single blood collection for a variety of molecular genetics/epidemiologic studies.
PMCID: PMC3818442  PMID: 24176175
DNA extraction; Granulocytes in separation medium; Whole blood
6.  Gravity sedimentation of granulocytapheresis concentrates with hydroxyethyl starch efficiently removes red blood cells and retains neutrophils 
Transfusion  2010;50(6):1203-1209.
Transfusion of granulocytapheresis concentrates can be limited by the volume of incompatible donor red blood cells (RBCs) in the component. Efficient reduction of RBCs in granulocyte units would result in safe transfusion of RBC-incompatible units.
Granulocyte concentrates were collected by continuous-flow apheresis from granulocyte–colony-stimulating factor (G-CSF) and dexamethasone-stimulated volunteer donors, with 6% hydroxyethyl starch (HES) added continuously during apheresis as a RBC sedimenting agent to enhance granulocyte collection efficiency. After collection, the component was placed in a plasma extractor for 4 hours. A sharp line of demarcation between the starch-sedimented RBCs and the granulocyte-rich supernatant developed, and the supernatant was transferred to a sterilely docked transfer pack. RBC reduction and white blood cell recovery were determined.
Gravity sedimentation was performed on 165 granulocyte concentrates. Mean sedimentation time was 267 minutes (range, 150–440 min). RBC depletion was 92% (range, 71%–99%) with mean residual RBC content of 3.2 ± 1.4 mL. Twelve percent of components contained less than 2 mL of RBCs. Mean granulocyte and platelet (PLT) recoveries were 80 and 81%, respectively. There were no transfusion reactions or signs of hemolysis after transfusion of 66 RBC-incompatible granulocyte concentrates (RBC volume, 1.6–8.2 mL). The remaining concentrates were used for topical or intrapleural applications.
RBCs were significantly reduced and granulocytes and PLTs effectively retained in G-CSF/ steroid–mobilized granulocyte components collected with HES and processed by gravity sedimentation. This procedure allows safe transfusion of RBC-incompatible sedimented granulocyte units and may be used to expand the pool of available granulocyte donors for specific recipients.
PMCID: PMC3421031  PMID: 20113453
7.  Effectiveness of confidential unit exclusion in screening blood donors of the regional blood bank in Londrina, Paraná State 
For transfusion purposes, blood donors must be accepted both in clinical and serological evaluations and must not have excluded their own donation using the confidential unit exclusion.
The objective of this study was to verify whether blood donors who choose self exclusion are more likely to be positive in serological tests than donors who do not.
A cross-sectional analysis was carried out of 51,861 consecutive whole blood donations from January 2004 to December 2008 at a public blood bank in Londrina, Southern Brazil.
Self exclusion was chosen in 1672 (3.2%) donations, most frequently by first-time blood donors (p-value < 0.0001), by blood donors from external collections (p-value < 0.0001), by men (p value < 0.0001) and by under 30-year-old donors (p-value < 0.0001). The frequency of positive serology was 5.3% in the group that chose self exclusion and 3.5% in the group that did not choose self exclusion (p-value < 0.0001).
These results show that confidential unit exclusion used in this blood bank is effective and is inexpensive. However, the diagnostic power to detect blood-borne infections was low and resulted in the discard of a high number of blood bags without any direct or indirect serologic markers of pathogens. The use of confidential unit exclusion could be replaced with molecular tests to screen blood donors.
PMCID: PMC3415772  PMID: 23049338
Donor selection; Serologic tests; Diagnosis; Blood transfusion
8.  What happens to donated blood? 
Pursuing their chief work--gathering, processing and distributing blood--the blood donor centres of the Canadian Red Cross Society follow standard operating procedures like those in place at the Ottawa centre. Here, recruitment staff and volunteers work to recruit donors to meet needs at a time when the number of donors is falling. When they register, donors must show proof of identity. Each receives a permanent identification number that is linked to the numbers assigned to the units of blood each donates and to the date the unit was collected and the centre that collected it. Donors must answer questions about health and high-risk activity, and the blood of those who report high-risk activity is not accepted. Units are screened by automated instruments for syphilis, hepatitis B and C, HIV types 1 and 2, and human T-cell leukemia virus. Units with a negative test result are broken down into components for use in hospitals. A reactive test result prompts quarantining of the unit and a second screening test. If this test result is also reactive, a sample of the unit is sent to the National Testing Laboratory for confirmatory testing, and the unit is discarded. Once it has the results of the confirmatory test, the centre contacts the donor. Blood is now considered a drug. Red Cross practices in Canada and around the world have been changing since 1989 to reflect this.
PMCID: PMC1337706  PMID: 7859200
9.  Low-Density Lipoprotein Apheresis 
Executive Summary
To assess the effectiveness and safety of low-density lipoprotein (LDL) apheresis performed with the heparin-induced extracorporeal LDL precipitation (HELP) system for the treatment of patients with refractory homozygous (HMZ) and heterozygous (HTZ) familial hypercholesterolemia (FH).
Background on Familial Hypercholesterolemia
Familial hypercholesterolemia is a genetic autosomal dominant disorder that is caused by several mutations in the LDL-receptor gene. The reduced number or absence of functional LDL receptors results in impaired hepatic clearance of circulating low-density lipoprotein cholesterol (LDL-C) particles, which results in extremely high levels of LDL-C in the bloodstream. Familial hypercholesterolemia is characterized by excess LDL-C deposits in tendons and arterial walls, early onset of atherosclerotic disease, and premature cardiac death.
Familial hypercholesterolemia occurs in both HTZ and HMZ forms.
Heterozygous FH is one of the most common monogenic metabolic disorders in the general population, occurring in approximately 1 in 500 individuals1. Nevertheless, HTZ FH is largely undiagnosed and an accurate diagnosis occurs in only about 15% of affected patients in Canada. Thus, it is estimated that there are approximately 3,800 diagnosed and 21,680 undiagnosed cases of HTZ FH in Ontario.
In HTZ FH patients, half of the LDL receptors do not work properly or are absent, resulting in plasma LDL-C levels 2- to 3-fold higher than normal (range 7-15mmol/L or 300-500mg/dL). Most HTZ FH patients are not diagnosed until middle age when either they or one of their siblings present with symptomatic coronary artery disease (CAD). Without lipid-lowering treatment, 50% of males die before the age of 50 and 25% of females die before the age of 60, from myocardial infarction or sudden death.
In contrast to the HTZ form, HMZ FH is rare (occurring in 1 case per million persons) and more severe, with a 6- to 8-fold elevation in plasma LDL-C levels (range 15-25mmol/L or 500-1000mg/dL). Homozygous FH patients are typically diagnosed in infancy, usually due to the presence of cholesterol deposits in the skin and tendons. The main complication of HMZ FH is supravalvular aortic stenosis, which is caused by cholesterol deposits on the aortic valve and in the ascending aorta. The average life expectancy of affected individuals is 23 to 25 years. In Ontario, it is estimated that there are 13 to 15 cases of HMZ FH. An Ontario clinical expert confirmed that 9 HMZ FH patients have been identified to date.
There are 2 accepted clinical diagnostic criterion for the diagnosis of FH: the Simon Broome FH Register criteria from the United Kingdom and the Dutch Lipid Network criteria from the Netherlands. The criterion supplement cholesterol levels with clinical history, physical signs and family history. DNA-based-mutation-screening methods permit a definitive diagnosis of HTZ FH to be made. However, given that there are over 1000 identified mutations in the LDL receptor gene and that the detection rates of current techniques are low, genetic testing becomes problematic in countries with high genetic heterogeneity, such as Canada.
The primary aim of treatment in both HTZ and HMZ FH is to reduce plasma LDL-C levels in order to reduce the risk of developing atherosclerosis and CAD.
The first line of treatment is dietary intervention, however it alone is rarely sufficient for the treatment of FH patients. Patients are frequently treated with lipid-lowering drugs such as resins, fibrates, niacin, statins and cholesterol absorption-inhibiting drugs (ezetimibe). Most HTZ FH patients require a combination of drugs to achieve or approach target cholesterol levels.
A small number of HTZ FH patients are refractory to treatment or intolerant to lipid-lowering medication. According to clinical experts, the prevalence of refractory HTZ FH in Ontario is between 1 to 5%. Using the mean of 3%, it is estimated that there are approximately 765 refractory HTZ FH patients in Ontario, of which 115 are diagnosed and 650 are undiagnosed.
Drug therapy is less effective in HMZ FH patients since the effects of the majority of cholesterol-lowering drugs are mediated by the upregulation of LDL receptors, which are often absent or function poorly in HMZ FH patients. Some HMZ FH patients may still benefit from drug therapy, however this rarely reduces LDL-C levels to targeted levels.
Existing Technology: Plasma Exchange
An option currently available in Ontario for FH patients who do not respond to standard diet and drug therapy is plasma exchange (PE). Patients are treated with this lifelong therapy on a weekly or biweekly basis with concomitant drug therapy.
Plasma exchange is nonspecific and eliminates virtually all plasma proteins such as albumin, immunoglobulins, coagulation factors, fibrinolytic factors and HDL-C, in addition to acutely lowering LDL-C by about 50%. Blood is removed from the patient, plasma is isolated, discarded and replaced with a substitution fluid. The substitution fluid and the remaining cellular components of the blood are then returned to the patient.
The major limitation of PE is its nonspecificity. The removal of HDL-C prevents successful vascular remodeling of the areas stenosed by atherosclerosis. In addition, there is an increased susceptibility to infections, and costs are incurred by the need for replacement fluid. Adverse events can be expected to occur in 12% of procedures.
Other Alternatives
Surgical alternatives for FH patients include portocaval shunt, ileal bypass and liver transplantation. However, these are risky procedures and are associated with a high morbidity rate. Results with gene therapy are not convincing to date.
The Technology Being Reviewed: LDL Apheresis
An alternative to PE is LDL apheresis. Unlike PE, LDL apheresis is a selective treatment that removes LDL-C and other atherogenic lipoproteins from the blood while minimally impacting other plasma components such as HDL-C, total serum protein, albumin and immunoglobulins. As with PE, FH patients require lifelong therapy with LDL apheresis on a weekly/biweekly basis with concomitant drug therapy.
Heparin-Induced Extracorporeal LDL Precipitation
Heparin-induced extracorporeal LDL precipitation (HELP) is one of the most widely used methods of LDL apheresis. It is a continuous closed-loop system that processes blood extracorporeally. It operates on the principle that at a low pH, LDL and lipoprotein (a) [Lp(a)] bind to heparin and fibrinogen to form a precipitate which is then removed by filtration. In general, the total duration of treatment is approximately 2 to 3 hours.
Results from early trials indicate that LDL-C concentration is reduced by 65% to 70% immediately following treatment in both HMZ and HTZ FH and then rapidly begins to rise. Typically patients with HTZ FH are treated every 2 weeks while patients with HMZ FH require weekly therapy. Heparin-induced extracorporeal LDL precipitation also produces small transient decreases in HDL-C, however levels generally return to baseline within 2 days. After several months of therapy, long-term reductions in LDL-C and increases in HDL-C have been reported.
In addition to having an impact on plasma cholesterol concentrations, HELP lowers plasma fibrinogen, a risk factor for atherosclerosis, and reduces concentrations of cellular adhesion molecules, which play a role in early atherogenesis.
In comparison with PE, HELP LDL apheresis does not have major effects on essential plasma proteins and does not require replacement fluid, thus decreasing susceptibility to infections. One study noted that adverse events were documented in 2.9% of LDL apheresis treatments using the HELP system compared with 12% using PE. As per the manufacturer, patients must weigh at least 30kgs to be eligible for treatment with HELP.
Regulatory Status
The H.E.L.P.® System (B.Braun Medizintechnologie GmbH, Germany) has been licensed by Health Canada since December 2000 as a Class 3 medical device (Licence # 26023) for performing LDL apheresis to acutely remove LDL from the plasma of 3 high-risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated. The 3 patient groups are as follows:
Functional hypercholesterolemic homozygotes with LDL-C >500 mg/dL (>13mmol/L);
Functional hypercholesterolemic heterozygotes with LDL-C >300 mg/dL (>7.8mmol/L);
Functional hypercholesterolemic heterozygotes with LDL-C >200 mg/dL (>5.2mmol/L) and documented CAD
No other LDL apheresis system is currently licensed in Canada.
Review Strategy
The Medical Advisory Secretariat systematically reviewed the literature to assess the effectiveness and safety of LDL apheresis performed with the HELP system for the treatment of patients with refractory HMZ and HTZ FH. A standard search methodology was used to retrieve international health technology assessments and English-language journal articles from selected databases.
The GRADE approach was used to systematically and explicitly make judgments about the quality of evidence and strength of recommendations.
Summary of Findings
The search identified 398 articles published from January 1, 1998 to May 30, 2007. Eight studies met the inclusion criteria. Five case series, 2 case series nested within comparative studies, and one retrospective review, were included in the analysis. A health technology assessment conducted by the Alberta Heritage Foundation for Medical Research, and a review by the United States Food and Drug Administration were also included.
Large heterogeneity among the studies was observed. Studies varied in inclusion criteria, baseline patient characteristics and methodology.
Overall, the mean acute1 relative decrease in LDL-C with HELP LDL apheresis ranged from 53 to 77%. The mean acute relative reductions ranged as follows: total cholesterol (TC) 47 to 64%, HDL-C +0.4 to -29%, triglycerides (TG) 33 to 62%, Lp(a) 55 to 68% and fibrinogen 56 to 65%.
The mean chronic2 relative decreases in LDL-C and TC with HELP LDL apheresis ranged from 9 to 46% and 5 to 34%, respectively. Familial hypercholesterolemia patients treated with HELP did not achieve the target LDL-C value set by international guidelines (LDL-C < 2.5mmol/L, 100mg/dL). The chronic mean relative increase in HDL-C ranged from 12 to 27%. The ratio of LDL:HDL and the ratio of TC:HDL are 2 measures that have been shown to be important risk factors for cardiac events. In high-risk patients, the recommended target LDL:HDL ratio is less than or equal to 2, and the target TC:HDL ratio is less than 4. In the studies that reported chronic lipid changes, the LDL:HDL and TC:HDL ratios exceeded targeted values.
Three studies investigated the effects of HELP on coronary outcomes and atherosclerotic changes. One noted that twice as many lesions displayed regression in comparison to those displaying progression. The second study found that there was a decrease in Agatston scores3 and in the volume of coronary calcium. The last study noted that 2 of 5 patients showed regression of coronary atherosclerosis, and 3 of the 5 patients showed no change as assessed by a global change score.
Adverse effects were typically mild and transient, and the majority of events were related to problems with vascular access. Of the 3 studies that provided quantitative information, the proportion of adverse events ranged from 2.9 to 5.1%.
GRADE Quality of Evidence
In general, studies were of low quality, i.e., case series studies (Tables 1-3). No controlled studies were identified and no studies directly compared the effectiveness of the HELP system with PE or with diet and drug therapy. Conducting trials with a sufficiently large control group would not have been feasible or acceptable given that HELP represents a last alternative in these patients who are resistant to conventional therapeutic strategies.
A major limitation is that there is limited evidence on the effectiveness and safety of HELP apheresis in HMZ FH patients. However, it is unlikely that better-quality evidence will become available, given that HMZ FH is rare and LDL apheresis is a last therapeutic option for these patients.
Lastly, there is limited data on the long-term effects of LDL apheresis in FH patients. No studies with HELP were identified that examined long-term outcomes such as survival and cardiovascular events. The absence of this data may be attributed to the rarity of the condition, and the large number of subjects and long duration of follow-up that would be needed to conduct such trials.
Homozygous Familial Hypercholesterolemia - Lipid Outcomes
Heterozygous Familial Hypercholesterolemia - Lipid Outcomes
Heterozygous Familial Hypercholesterolemia - Coronary Artery Disease Outcomes
Economic Analysis
A budget-impact analysis was conducted to forecast future costs for PE and HELP apheresis in FH patients. All costs are reported in Canadian dollars. Based on epidemiological data of 13 HMZ, 115 diagnosed HTZ and 765 cases of all HTZ patients (diagnosed + undiagnosed), the annual cost of weekly treatment was estimated to be $488,025, $4,332,227 and $24,758,556 respectively for PE. For HELP apheresis, the annual cost of weekly treatment was estimated to be $1,025,338, $9,156,209 and $60,982,579 respectively. Costs for PE and HELP apheresis were halved with a biweekly treatment schedule.
The cost per coronary artery disease death avoided over a 10-year period in HTZ FH-diagnosed patients was also calculated and estimated to be $37.5 million and $18.7 million for weekly and biweekly treatment respectively, when comparing HELP apheresis with PE and with no intervention. Although HELP apheresis costs twice as much as PE, it helped to avoid 12 deaths compared with PE and 22 deaths compared with no intervention, over a period of 10 years.
Ontario Health System Impact Analysis
Low-density lipoprotein apheresis using the HELP system is currently being funded by the provinces of Quebec and Alberta. The program in Quebec has been in operation since 2001 and is limited to the treatment of HMZ FH patients. The Alberta program is relatively new and is currently treating HMZ FH patients, but it is expanding to include refractory HTZ FH patients.
Low-density lipoprotein apheresis is a lifelong treatment and requires considerable commitment on the part of the patient, and the patient’s family and physician. In addition, the management of FH continues to evolve. With the advent of new more powerful cholesterol-lowering drugs, some HTZ patients may be able to sufficiently control their hypercholesterolemia. Nevertheless, according to clinical experts, HMZ patients will likely always require LDL apheresis.
Given the substantial costs associated with LDL apheresis, treatment has been limited to HMZ FH patients. However, LDL apheresis could be applied to a much larger population, which would include HTZ FH patients who are refractory to diet and drug therapy. HTZ FH patients are generally recruited in a more advanced state, demonstrate a longer natural survival than HMZ FH patients and are older.
For HMZ FH patients, the benefits of LDL apheresis clearly outweigh the risks and burdens. According to GRADE, the recommendation would be graded as strong, with low- to very low-quality evidence (Table 4).
In both HMZ and HTZ FH patients, there is evidence of overall clinical benefit of LDL apheresis from case series studies. Low-density lipoprotein apheresis has several advantages over the current treatment of PE, including decreased exposure to blood products, decreased risk of adverse events, conservation of nonatherogenic and athero-protective components, such as HDL-C and lowering of other atherogenic components, such as fibrinogen.
In contrast to HMZ FH patients, there remains a lot of uncertainty in the social/ethical acceptance of this technology for the treatment of refractory HTZ FH patients. In addition to the substantial costs, it is unknown whether the current health care system could cope with the additional demand. There is uncertainty in the estimates of benefits, risks and burdens. According to GRADE, the recommendation would be graded as weak with low- to very-low-quality evidence (Table 5).
GRADE Recommendation - Homozygous Patients
GRADE of recommendation: Strong recommendation, low-quality or very-low-quality evidence
Benefits clearly outweigh risk and burdens
Case series study designs
Strong, but may change when higher-quality evidence becomes available
GRADE Recommendation - Heterozygous Patients
GRADE of recommendation: Weak recommendation, low-quality or very-low-quality evidence
Uncertainty in the estimates of benefits, risks and burden, which these may be closely balanced
Case series study designs
Very weak; other alternatives may be equally reasonable
PMCID: PMC3377562  PMID: 23074505
10.  Quality of Red Blood Cells Isolated from Umbilical Cord Blood Stored at Room Temperature 
Journal of blood transfusion  2011;2012:102809.
Red blood cells (RBCs) from cord blood contain fetal hemoglobin that is predominant in newborns and, therefore, may be more appropriate for neonatal transfusions than currently transfused adult RBCs. Post-collection, cord blood can be stored at room temperature for several days before it is processed for stem cells isolation, with little known about how these conditions affect currently discarded RBCs. The present study examined the effect of the duration cord blood spent at room temperature and other cord blood characteristics on cord RBC quality. RBCs were tested immediately after their isolation from cord blood using a broad panel of quality assays. No significant decrease in cord RBC quality was observed during the first 65 hours of storage at room temperature. The ratio of cord blood to anticoagulant was associated with RBC quality and needs to be optimized in future. This knowledge will assist in future development of cord RBC transfusion product.
PMCID: PMC3777252  PMID: 24089645
11.  Stored Platelet Functionality is Not Decreased After Warming with a Fluid Warmer 
Anesthesia and analgesia  2013;117(3):575-578.
Warming of IV administered fluids and blood products is routinely performed in the operating room to help maintain normothermia. Current guidelines recommend against the warming of platelets (PLTs), although there is no evidence for this prohibition in the literature. Our goal in this pilot study was to determine if the warming of stored PLTs had any effect on their function.
Ten units of three-day-old PLT rich plasma-derived whole blood PLTs were acquired from the transfusion service. A 5 mL aliquot was taken from each unit before warming (control samples). The remainder of the unit was then passed into a blood warming device and held there for two minutes. Post-warming (warmed) PLT samples were then collected from the effluent end of the warming device. PLT aggregometry assays with adenosine diphosphate, collagen, and arachidonic acid as agonists were performed on the control and warmed samples. Thromboelastrography (TEG®) tests were also performed on the control and warmed samples from six of the 10 PLT units.
The mean temperature of the control and warmed samples was 22.4 ± 0.5°C and 37.8 ± 2.3°C, respectively. There was no significant difference (all P ≥ 0.13) in any of the PLT aggregometry assays or in the maximum amplitude of the TEG® test between the control and the warmed samples. The observed mean of only one parameter decreased (PLT aggregometry with 5 µM adenosine diphosphate), by 5% (95% CI: −115% to 105%). The maximum change observed was PLT aggregometry with arachidonic acid as agonist, which increased by 116% (95% CI: −91% to 323%).
Although small in size, the results of this study do not support the prohibition against mechanical PLT warming. Studies of PLT activation after warming are also warranted.
PMCID: PMC3784352  PMID: 23921655
12.  Anti-HBc screening in Indian blood donors: Still an unresolved issue 
AIM: To study the seroprevalence of antibody to hepatitis B core antigen (anti-HBc) in healthy blood donors negative for HBsAg and to evaluate whether anti-HBc detection could be adopted in India as a screening assay for HBV in addition to HBsAg.
METHODS: A total of 1700 serum samples collected from HBsAg-negative healthy blood donors were tested for the presence of anti-HBc antibody (IgM + IgG). All samples reactive for anti-HBc antibody were then investigated for presence of anti-HBs and for liver function tests (LFTs). One hundred serum samples reactive for anti-HBc were tested for HBV DNA by PCR method.
RESULTS: Out of 1700 samples tested, 142 (8.4%) blood samples were found to be reactive for anti-HBc. It was significantly lower in voluntary (6.9%) as compared to replacement donors (10.4%, P = 0.011). Seventy-two (50.7%) anti-HBc reactive samples were also reactive for anti-HBs with levels > 10 mIU/mL and 70 (49.3%) samples were non-reactive for anti-HBs, these units were labeled as anti-HBc-only. These 142 anti-HBc reactive units were also tested for liver function test. HBV DNA was detected in only 1 of 100 samples tested.
CONCLUSION: Keeping in view that 8%-18% of donor population in India is anti-HBc reactive, inclusion of anti-HBc testing will lead to high discard rate. Anti-HBs as proposed previously does not seem to predict clearance of the virus. Cost effectiveness of introducing universal anti-HBc screening and discarding large number of blood units versus considering ID NAT (Individual donor nuclic acid testing) needs to be assessed.
PMCID: PMC2744065  PMID: 18785287
Hepatitis B core antigen; Hepatitis B surface antigen; Hepatitis B virus; Transfusion-associated hepatitis B virus; Blood donors
13.  Report on Notifications Pursuant to §21 German Transfusion Act for 2007 
The present report contains the data collected in 2007, pursuant to Section 21 German Transfusion Act, and an analysis of the supply situation over the past 8 years. As in previous years, all blood donation centres located in Germany transmitted data on the collection, manufacture, import and export of blood components for transfusion. According to these data, a total of 6.7 million blood collections were performed in 2007. With 4.7 million, the portion of whole blood donations was at the level of previous years, whereas the number of apheresis donations rose again, to 1.9 million. The portion of autologous blood collections accounts for only 1.1% and thus continues to decline. Since 2003, the number of red blood cell concentrates prepared has been a constant 4.5 million transfusion units. The decay of red blood cell concentrates on the user side in 2000 accounted for 5% while in 2007 it was just above 3%, referred to the total quantity of data reported as transfused and decayed. The manufacture of platelet concentrates rose from 366,000 to 480,000 transfusion units between 2003 and 2007. The production of therapeutic single plasmas, too, markedly increased in 2007 (to 1.2 million transfusion units). In 2007, 2.2 million I of plasma for fractionation were collected in Germany. In addition, 1.0 million I were imported, and 1.8 million I were exported. The quantity available in Germany from a pure arithmetic point of view of 1.4 million I was almost entirely allocated to basic fractionation so that a sufficient plasma supply can be assumed. Due to the fact that manufacturing capacities are still lacking in Germany, recombinant factors need to be imported in their entirety. Since 2003, Germany has by far been the leader in Europe with more than 20 I of fractionation plasma collected per 1,000 inhabitants. Furthermore, regarding the manufacturing figures of red blood cell concentrates, platelet concentrates, and therapeutic single plasma, Germany is in the top third for all these products compared with other European countries. The manufacture of allogeneic stem cell products for haematopoietic reconstitution, obtained by apheresis, has continuously risen to 4,700. A large portion of this (1,810 transplants) could be exported while only a small number (179 preparations) had to be imported. The manufacture of autologous stem cell preparations from cord blood has risen drastically to more than 10,000 in 2007. The interest in the figures collected in compliance with Section 21, German Transfusion Act remains high both in Germany and at an international level. Meanwhile reliable data are available.
PMCID: PMC2914406  PMID: 20737014
Blood donations; Erythrocyte concentrates; Plasma for fractionation; Blood coagulation factors; Supply situation
14.  Freezer anthropology: new uses for old blood. 
Archived blood fractions (plasma, settled red cells, white cells) have proved to be a rich and valuable source of DNA for human genetic studies. Large numbers of such samples were collected between 1960 and the present for protein and blood group studies, many of which are languishing in freezers or have already been discarded. More are discarded each year because the usefulness of these samples is not widely understood. Data from DNA derived from 10-35-year-old blood samples have been used to address the peopling of the New World and of the Pacific. Mitochondrial DNA haplotypes from studies using this source DNA support a single wave of migration into the New World (or a single source population for the New World), and that Mongolia was the likely source of the founding population. Data from Melanesia have shown that Polynesians are recent immigrants into the Pacific and did not arise from Melanesia.
PMCID: PMC1692452  PMID: 10091252
15.  Retrospective Analysis of the Blood Component Utilization in a University Hospital of Maximum Medical Care 
Demographic data illustrate clearly that people in highly developed countries get older, and the elderly need more blood transfusions than younger patients. Additionally, special extensive therapies result in an increased consumption of blood components. Beyond that the aging of the population reduces the total number of preferably young and healthy blood donors. Therefore, Patient Blood Management will become more and more important in order to secure an increasing blood supply under fair-minded conditions.
At the University Hospital of Münster (UKM) a comprehensive retrospective analysis of the utilization of all conventional blood components was performed including all medical and surgical disciplines. In parallel, a new medical reporting system was installed to provide a monthly analysis of the transfusional treatments in the whole infirmary, in every department, and in special blood-consuming cases of interest, as well.
The study refers to all UKM in-patient cases from 2009 to 2011. It clearly demonstrates that older patients (>60 years, 35.2–35.7% of all cases, but 49.4–52.6% of all cases with red blood cell (RBC) transfusions, 36.4–41. 6% of all cases with platelet (PTL, apheresis only) transfusions, 45.2–48.0% of all cases with fresh frozen plasma (FFP) transfusions) need more blood products than younger patients. Male patients (54.4–63.9% of all cases with transfusions) are more susceptible to blood transfusions than female patients (36.1–45.6% of all cases with transfusions). Most blood components are used in cardiac, visceral, and orthopedic surgery (49.3–55.9% of all RBC units, 45.8–61.0% of all FFP units). When regarding medical disciplines, most transfusions are administered to hematologic and oncologic patients (12.9–17.7% of all RBC units, 9.2–12.0% of all FFP units). The consumption of PTL in this special patient cohort (40.6–50.9% of all PTL units) is more pronounced than in all other surgical or in non-surgical disciplines.
The results obtained from our retrospective analysis may help to further optimize the responsible and medical indication-related utilization of blood transfusions as well as the recruitment of blood donors and their timing. It may be also a helpful tool in order to avoid needless transfusions and transfusionassociated adverse events.
PMCID: PMC3364044  PMID: 22670131
Patient blood management; Blood supply; Consumption of blood products; Hemotherapy; Medical reporting system; Demography; Process management; Health services research
16.  Hemostatic Function and Transfusion Efficacy of Apheresis Platelet Concentrates Treated with Gamma Irradiation in Use for Thrombocytopenic Patients 
During the transfusion of blood components, the transfer of allogeneic donor white blood cells (WBCs) can mediate transfusion-associated graft-versus-host disease (TA-GVHD). To minimize the reaction, exposure of blood products to gamma irradiation is currently the standard of care. The aim of our study was to evaluate and compare hemostatic function, transfusion efficacy, and safety of gamma-irradiated single-donor apheresis platelet concentrates (PCs) and of conventional non-irradiated PCs in patients with chemotherapy-induced thrombocytopenia.
20 double-dose single-donor leukoreduced PCs were split in two identical units; one was gamma-irradiated with 25 Gy (study arm A) and the other remains non-irradiated (study arm B). Both units were stored under equal conditions. Hematologic patients were randomly assigned to receive gamma-irradiated or conventional non-irradiated PCs. Hemostatic function was evaluated by thrombelastography (TEG). TEG measurements were taken pre transfusion and 1 and 24 h post transfusion. TEG profiles were measured, noting the time to initiate clotting (R), the angle of clot formation (α), and the maximum amplitude (clot strength (MA)). Whole blood samples were collected from these thrombocytopenic patients at 1 and 24 h for PLT count increments (CIs) and corrected count increments (CCIs) with assessments of transfusion efficacy. Time to next PLT transfusion, transfusion requirement of RBCs, active bleeding, and adverse events (AEs), were analyzed.
No differences could be found in hemostatic function parameters (MA, R, and α) between study arms A and B (all p values > 0.096) pre transfusion as well as 1 and 24 h post transfusion. No differences between study arms A and B were observed for mean (± standard deviation (SD)) 1-hour CCI (12.83 ± 6.33 vs. 11.59 ± 5.97) and 24-hour CCI (6.56 ± 4.10 vs. 5.76 ± 4.05). Mean 1-hour CI and 24-hour CI were not significantly different in both study arms (p = 0.254 and p = 0.242 respectively). Median time to the next PC transfusion after study PC was not significantly different between groups: (2.4 vs. 2.2 days, p = 0.767). No differences could be found in transfusion requirement of red blood cells (p = 0.744) between both study arms. There were also no regarding bleeding, adverse events, and acute transfusion reaction(s).
This study confirms safety of gamma-irradiated PCs for treatment thrombocytopenia. Hemostatic function, transfusion efficacy, bleeding, and safety of single-donor apheresis PCs treated with gamma irradiation versus untreated control PCs are comparable.
PMCID: PMC4086760  PMID: 25053932
Hemostatic function; Transfusion efficacy; Apheresis platelet concentrates; Gamma irradiation; Thrombocytopenic patients
17.  Storage of whole blood overnight in different blood bags preceding preparation of blood components: in vitro effects on red blood cells 
Blood Transfusion  2009;7(3):210-215.
Routines for the storage of whole blood (WB) overnight for the preparation of blood components on the following day are of increasing interest primarily for logistic reasons. The present study focuses on in vitro effects during storage for 6 weeks on red blood cells (RBC) prepared in different blood containers after being held overnight.
Study design and methods
Five different blood collection systems were used with either inline leucocyte reduction red cell filters for the preparation of RBC, buffy coat (BC) and plasma or WB filters for the preparation of RBC and plasma. A new container with an integrated WB filter removing leucocytes but not platelets was also included for the preparation of leucocyte-reduced RBC, BC and plasma units. Standard CPD solution (63 or 70 mL) and SAG-M solution (100 or 110 mL) were used for the collection of either 450 or 500 mL blood. All WB units were stored at room temperature, either overnight for 18–24 hours (test groups, n=104) or for up to 8 hours (reference groups, n=20). In addition, five test units were stored overnight under refrigeration.
In test groups (overnight storage at room temperature) we found significantly lower levels of extracellular potassium, 2,3-DPG and pH (up to day 28). During storage, higher levels of ATP (Terumo, CaridianBCT until day 35, Fresenius until day 14, Fenwal throughout storage) were seen in test groups than in reference groups. When WB was stored overnight at 2–6°C before WB filtration, the levels of ATP and haemolysis were higher than in the corresponding reference.
Significant differences in in vitro parameters were observed between RBC prepared within 8 hours and 18–24 hours after blood collection. The results were consistent irrespective of the blood container used. New alkaline solutions may decrease the differences.
PMCID: PMC2719273  PMID: 19657485
red blood cells; overnight; storage; in vitro; ATP; 2,3-DPG
18.  High prevalence of vitamin D insufficiency and its association with obesity and metabolic syndrome among Malay adults in Kuala Lumpur, Malaysia 
BMC Public Health  2011;11:735.
Vitamin D status, as indicated by 25-hydroxyvitamin D is inversely associated with adiposity, glucose homeostasis, lipid profiles, and blood pressure along with its classic role in calcium homeostasis and bone metabolism. It is also shown to be inversely associated with metabolic syndrome and cardiovascular diseases in western populations. However, evidence from the Asian population is limited. Therefore, we aim to study the prevalence of vitamin D insufficiency (< 50 nmol/L) and the association of 25-hydroxyvitamin D with metabolic risk factors among an existing Malay cohort in Kuala Lumpur.
This is an analytical cross sectional study. A total of 380 subjects were sampled and their vitamins D status (25-hydroxyvitamin D), fasting blood glucose, full lipid profile were assessed using venous blood. Systolic and diastolic blood pressure, weight, height and waist circumference were measured following standard protocols. Socio-demographic data such as sex, age, smoking status etc were also collected. Data was analysed using t-test, chi-square test, General Linear Model and multiple logistic regression.
Females made up 58% of the sample. The mean age of respondents was 48.5 (SD 5.2) years. Females had significantly lower mean Vitamin D levels (36.2; 95% CI: 34.5, 38.0 nmol/L) compared to males (56.2; 95% CI: 53.2, 59.2 nmol/L). Approximately 41% and 87% of males and females respectively had insufficient (< 50 nmol/L) levels of 25-hydroxyvitamin D (p < 0.001). The prevalence of Metabolic Syndrome for the whole sample was 38.4 (95% CI: 33.5, 43.3)%. In the multivariate model (adjusted for age, sex, abdominal obesity, HDL-cholesterol, diastolic blood pressure), insufficient Vitamin D status was significantly associated with 1-year age increments (OR: 0.93; 95% CI: 0.88, 0.98), being female (OR: 8.68; 95% CI: 5.08, 14.83) and abdominal obesity (OR: 2.57; 95% CI: 1.51, 4.39). Respondents with insufficient vitamin D were found to have higher odds of having Metabolic Syndrome (OR: 1.73; 95% CI: 1.02, 2.92) after adjusting for age and sex.
Our results highlight the high prevalence of vitamin D insufficiency among Malay adults in Kuala Lumpur. Vitamin D insufficiency is independently associated with younger age, female sex and greater abdominal obesity. Vitamin D insufficiency is also associated with Metabolic Syndrome.
PMCID: PMC3198705  PMID: 21943301
19.  Blood product ratio in acute traumatic coagulopathy - effect on mortality in a Scandinavian level 1 trauma centre 
Trauma is the leading cause of loss of life expectancy worldwide. In the most seriously injured patients, coagulopathy is often present on admission. Therefore, transfusion strategies to increase the ratio of plasma (FFP) and platelets (PLT) to red blood cells (RBC), simulating whole blood, have been introduced. Several studies report that higher ratios improve survival in massively bleeding patients. Here, the aim was to investigate the potential effect of increased FFP and PLT to RBC on mortality in trauma patients.
In a retrospective before and after study, all trauma patients primarily admitted to a level-one Trauma Centre, receiving blood transfusion, in 2001-3 (n = 97) and 2005-7 (n = 156), were included. In 2001-3, FFP and PLT were administered in accordance with the American Society of Anesthesiologists (ASA) guidelines whereas in 2005-7, Hemostatic Control Resuscitation (HCR) entailing pre-emptive use of FFP and PLT in transfusion packages during uncontrolled haemorrhage and thereafter guided by thrombelastograph (TEG) analysis was employed. The effect of transfusion therapy and coagulopathy on mortality was investigated.
Patients included in the early and late period had comparable demography, injury severity score (ISS), admission hematology and coagulopathy (27% vs. 34% had APTT above normal). There was a significant change in blood transfusion practice with shorter time interval from admission to first transfusion (median time 3 min vs.28 min in massive bleeders, p < 0.001), transfusion of higher ratios of FFP:RBC, PLT:RBC and PLT:FFP in the HCR group but 30-day mortality remained comparable in the two periods. In the 2005-7 period, higher age, ISS and Activated Partial Thromboplastin Time (APTT) above normal were independent predictors of mortality whereas no association was fund between blood product ratios and mortality.
Aggressive administration of FFP and PLT did not influence mortality in the present trauma population.
PMCID: PMC3004812  PMID: 21138569
20.  School Lunch Waste among Middle School Students: Implications for Nutrients Consumed and Food Waste Costs 
The National School Lunch Program has been guided by modest nutrient standards, and the palatability of meals, which drives consumption, receives inadequate attention. School food waste can have important nutritional and cost implications for policy makers, students, and their families.
Nutrient losses and economic costs associated with school meal waste were examined. The study also assessed if school foods served were valid proxies for foods consumed by students.
Plate waste measurements were collected from middle school students in Boston attending two Chef Initiative schools (n=1609) and two control schools (n=1440) during a two-year pilot study (2007-2009) where a professional chef trained cafeteria staff to make healthier school meals. The costs associated with food waste were calculated and the percent of foods consumed was compared with a gold standard of 85% consumption. Analyses were conducted in 2010-2011.
Overall, students consumed less than the required/recommended levels of nutrients. An estimated $432,349 of food (26.1% of the total food budget) was discarded by middle school students annually at lunch in Boston middle schools. For most meal components, significantly less than 85% was consumed.
There is substantial food waste among middle school students in Boston. Overall, students' nutrient consumption levels were below school meal standards and foods served were not valid proxies for foods consumed. The costs associated with discarded foods are high; if translated nationally for school lunches, roughly $1,238,846,400 annually is wasted. Students would benefit if additional focus was given to the quality and palatability of school meals.
PMCID: PMC3788640  PMID: 23332326
21.  Performance characteristics of a novel blood bag in-line closure device and subsequent product quality assessment 
Transfusion  2010;50(10):2240-2248.
In high-volume processing environments, manual breakage of in-line closures can result in repetitive strain injury (RSI). Furthermore, these closures may be incorrectly opened causing shear-induced hemolysis. To overcome the variability of in-line closure use and minimize RSI, Fresenius Kabi developed a new in-line closure, the CompoFlow, with mechanical openers.
The consistency of the performance of the CompoFlow closure device was assessed, as was its effect on component quality. A total of 188 RBC units using CompoFlow blood bag systems and 43 using the standard bag systems were produced using the buffy coat manufacturing method. Twenty-six CompoFlow platelet (PLT) concentrates and 10 control concentrates were prepared from pools of four buffy coats. RBCs were assessed on Days 1, 21, and 42 for cellular variables and hemolysis. PLTs were assessed on Days 1, 3, and 7 for morphology, CD62P expression, glucose, lactate, and pH. A total of 308 closures were excised after processing and the apertures were measured using digital image analysis.
The use of the CompoFlow device significantly improved the mean extraction time with 0.46 ± 0.11 sec/mL for the CompoFlow units and 0.52 ± 0.13 sec/mL for the control units. The CompoFlow closures showed a highly reproducible aperture after opening (coefficient of variation, 15%) and the device always remained opened. PLT and RBC products showed acceptable storage variables with no differences between CompoFlow and control.
The CompoFlow closure devices improved the level of process control and processing time of blood component production with no negative effects on product quality.
PMCID: PMC3039751  PMID: 20529007
22.  Determination of Rate and Causes of Wastage of Blood and Blood Products in Iranian Hospitals 
Turkish Journal of Hematology  2014;31(2):161-167.
Objective: The purpose of this study was to determine the rate and causes of wastage of blood and blood products (packed red cells, plasma, platelets, and cryoprecipitate) in Qazvin hospitals.
Materials and Methods: The study was conducted in all hospitals in Qazvin, including 5 teaching hospitals, 2 social welfare hospitals, 3 private hospitals, 1 charity hospital, and 1 military hospital. This descriptive study was based on available data from hospital blood banks in the province of Qazvin. The research instrument was a 2-part questionnaire. The first part was related to demographic characteristics of hospitals and the second part elicited information about blood and blood component wastage. The collected data were then analyzed using descriptive statistic methods and SPSS 11.5.
Results: Blood wastage may occur for a number of reasons, including time expiry, wasted imports, blood medically or surgically ordered but not used, stock time expired, hemolysis, or miscellaneous reasons. Data indicated that approximately 77.9% of wasted pack cell units were wasted for the reason of time expiry. Pack cell wastage in hospitals is reported to range from 1.93% to 30.7%. Wastage at all hospitals averaged 9.8% among 30.913 issued blood products. Overall blood and blood product (packed red cells, plasma, platelets, and cryoprecipitate) wastage was 3048 units and average total wastage per participant hospital for all blood groups was 254 units per year.
Conclusion: Blood transfusion is an essential part of patient care. The blood transfusion system has made significant advancements in areas such as donor management, storage of blood, cross-matching, rational use of blood, and distribution. In order to improve the standards of blood banks and the blood transfusion services in Iran, comprehensive standards have been formulated to ensure better quality control in collection, storage, testing, and distribution of blood and its components for the identified major factors affecting blood product wastage.
PMCID: PMC4102044  PMID: 25035674
Blood; Blood component; Wastage; Transfusion; Blood bank
23.  Platelet-rich-plasmapheresis for minimising peri-operative allogeneic blood transfusion 
Concerns regarding the safety of transfused blood have generated considerable enthusiasm for the use of technologies intended to reduce the use of allogeneic blood (blood from an unrelated donor). Platelet-rich plasmapheresis (PRP) offers an alternative approach to blood conservation.
To examine the evidence for the efficacy of PRP in reducing peri-operative allogeneic red blood cell (RBC) transfusion, and the evidence for any effect on clinical outcomes such as mortality and re-operation rates.
Search methods
We identified studies by searching MEDLINE (1950 to 2009), EMBASE (1980 to 2009), The Cochrane Library (Issue 1, 2009), the Internet (to March 2009) and the reference lists of published articles, reports, and reviews.
Selection criteria
Controlled parallel group trials in which adult patients, scheduled for non-urgent surgery, were randomised to PRP, or to a control group which did not receive the intervention.
Data collection and analysis
Primary outcomes measured were: the number of patients exposed to allogeneic RBC transfusion, and the amount of RBC transfused. Other outcomes measured were: the number of patients exposed to allogeneic platelet transfusions, fresh frozen plasma, and cryoprecipitate, blood loss, re-operation for bleeding, post-operative complications (thrombosis), mortality, and length of hospital stay. Treatment effects were pooled using a random-effects model. Trial quality was assessed using criteria proposed by Schulz et al (Schulz 1995).
Main results
Twenty-two trials of PRP were identified that reported data for the number of patients exposed to allogeneic RBC transfusion. These trials evaluated a total of 1589 patients. The relative risk (RR) of exposure to allogeneic blood transfusion in those patients randomised to PRP was 0.73 (95%CI 0.59 to 0.90), equating to a relative risk reduction (RRR) of 27% and a risk difference (RD) of 19% (95%CI 10% to 29%). However, significant heterogeneity of treatment effect was observed (p < 0.00001; I2 = 79%). When the four trials by Boldt are excluded, the RR is 0.76 (95% CI 0.62 to 0.93). On average, PRP did not significantly reduce the total volume of RBC transfused (weighted mean difference [WMD] −0.69, 95%CI −1.93 to 0.56 units). Trials provided inadequate data regarding the impact of PRP on morbidity, mortality, and hospital length of stay. Trials were generally small and of poor methodological quality.
Authors’ conclusions
Although the results suggest that PRP is effective in reducing allogeneic RBC transfusion in adult patients undergoing elective surgery, there was considerable heterogeneity of treatment effects and the trials were of poor methodological quality. The available studies provided inadequate data for firm conclusions to be drawn regarding the impact of PRP on clinically important endpoints.
PMCID: PMC4171963  PMID: 21412885
Blood Loss, Surgical [prevention & control]; Plasmapheresis [*methods]; Platelet Transfusion [*utilization]; Randomized Controlled Trials as Topic; Surgical Procedures, Elective; Transplantation, Homologous; Adult; Humans
24.  An Analysis of Bone Donor Deferral Rates in Scotland – a 6-Year Study 
The Scottish National Blood Transfusion Service (SNBTS) is the main provider of tissues in Scotland. Tissue collection programmes were established in the mid-1990s, and the range of tissues collected has increased progressively over the years.
Whilst the majority of tissues are obtained from cadaveric donations, bone is collected only from living donors who are usually patients undergoing primary hip replacement surgery (surgical donors). The bone is collected in an operating theatre, and, once stored, no further processing takes place prior to issue. Bone that fails for any reason (quality, microbiology or virological nonnegative result) is discarded.
The deferral rate amongst live surgical bone donors in Scotland is around 65%, and it has been slowly and progressively rising from around 55% over the past few years. This needed investigated, particularly because comparisons with blood donors show that the deferral rate amongst bone donors is more than double that of first-time blood donors (29.7%). Our processes and systems are standardised, and our cohort of bone bank nurses have all been similarly trained and competency assessed. Moreover our data collection was done in a uniform fashion. It was therefore possible to conduct a 6-year audit on bone donor deferrals. It was found that a history of transfusion (16%), history of malignancy (18%) and bone quality (26%) were the main reasons for bone donor deferrals, accounting for 60% of all deferrals.
When these are taken into account, the residual deferral rates become very similar numerically to blood donors. It is important to note however that there are significant differences between the blood and bone donor cohorts. This study also highlighted some of deferral reasons. Particularly malignancy is a cause of significant numbers of deferrals, and the evidence of transmissibility of malignancy through bone donation is not strong. More robust risk assessments should be undertaken prior to implementing deferral conditions.
PMCID: PMC3268000  PMID: 22403521
Living bone donors; Deferral rates; Tissue donation; Femoral head
25.  Changing Pattern of Organ Donation and Utilization in the USA 
Background: Organ transplantation has proven highly effective in the treatment of various forms of end-stage organ failure. However, organ shortage is still the greatest challenge facing the field of organ transplantation.
Objective: To assess the pattern of organ donation and utilization during the past decade in the USA.
Methods: We studied OPTN/UNOS database for organ donation between January 2000 and December 2009. The retrieved records were then categorized into two time periods—from January 2000 to December 2004 (era 1), and from January 2005 to December 2009 (era 2).
Results: There were 65,802 living and 71,401 deceased donors in the US from 2000 to 2009, including 66,518 (93.2%) brain-dead donors and 4,883 (6.8%) donation after cardiac death. Comparing two periods—from January 2000 to December 2004 (era 1) and from January 2005 to December 2009 (era 2), the number of deceased donors increased by 25% from 31,692 to 39,709 and living donors decreased by 7.6%. Donation after cardiac death increased from 3.5% to 9.3%. The portion of donors older than 64 years increased from 6.9% in era 1 to 11.3% in era 2 (p=0.03). The number of donors with a body mass index of >35 kg/m2 was also increased from 6.8% to 11.2%. A significant increase in the incidence of cardiovascular/cerebrovascular as cause of death was also noted from 38.1% in era 1 to 56.1% in era 2 (p<0.001), as was a corresponding decrease in the incidence of death due to head trauma (34.9% vs. 48.8%). The overall discard rate also increased by 41% from 13,411 in era 1 to 19,516 in era 2. This increase in discards was especially more prominent in donation after cardiac death group which rose by 374% from 440 in era 1 to 2,089 in era 2. The discard rate for livers and kidneys increased by 31% and 68%, respectively, comparing era 1 and era 2. We noted a 78% increase for discarded donation after cardiac death livers and 1,210% for discarded donation after cardiac death kidneys.
Conclusion: We detected significant changes in the make-up of the donor pool over the past decade in the US. Over time, donor characteristics have changed with increased numbers of elderly donors and donors with comorbidities, especially donors who died of cardiovascular/cerebrovascular disease. The incidence of donation after cardiac death has increased significantly; brain-dead donors have only increased slightly and living donors have decreased. As the result, the discard rates have increased. The transplant community and policy makers should consider every precaution to safeguard the donor pool and prevent the decay of organ quality in favor of quantity.
PMCID: PMC4089300  PMID: 25013640
Organ transplantation; End-stage organ failure; Brain-dead donor; Living donors

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