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Transfus Med Hemother. 2008 April; 35(2): 98–101.
Published online 2008 March 17. doi:  10.1159/000119120
PMCID: PMC3076342

Swiss Haemovigilance Data and Implementation of Measures for the Prevention of Transfusion Associated Acute Lung Injury (TRALI)

Abstract

Summary

In Switzerland, blood donations are collected exclusively from healthy non-remunerated voluntary blood donors mainly by 13 regional Blood Transfusion Services throughout the country. Thereby, self-sufficient blood supply for a population of about 7.5 million is achieved, and approximately 300,000 units of red cells, 75,000 therapeutic units of fresh plasma, and 20,000 therapeutic units of platelets are transfused annually. Reporting to Swissmedic (the Swiss agency for therapeutic products) of all suspected adverse transfusion events on a standardised form is mandatory. Data are then analysed to estimate the risks of the most serious transfusion events. Together with transfusion of an incorrect blood component and bacterial contamination of platelet concentrates, TRALI is a significant risk of transfusion in Switzerland and occurs in approximately every 8,000–20,000 FFP transfusions according to current haemovigilance data. Among 25 reported cases between 2002 and November 2007, 4 are proven immune TRALI, 2 are highly likely immune TRALI, 10 are possibly immune TRALI, 8 are non-immune TRALI, and 1 is a suspected case which could not be confirmed as TRALI. Based on the hypothesis of an immunological trigger of TRALI, an exclusion of the transfusion of plasma from female donors can be considered as a precautionary measure which might have prevented 4 cases of proven immune TRALI, 2 cases of highly likely immune TRALI, and an unknown number of the 10 cases of possibly immune TRALI. Based on these data and encouraging preliminary reports of the effects of comparable measures in other countries, the decision was made that starting with January 1st 2007 the production of quarantined FFP is restricted to donations from men or from women confirming that they have never been pregnant (to their knowledge) or with negative tests for antibodies against HLA class I and II. The analysis of further vigilance data is needed to elucidate the efficacy of this preventive measure.

Key Words: TRALI, Haemovigilance, Prevention, Transfusion risk

Introduction

Switzerland has a population of about 7.5 million. Approximately 300,000 units of red cells, 75,000 units of plasma (60,000 units of quarantine fresh frozen plasma (qFFP) and 15,000 units of solvent-detergent plasma (SD-P)) and 20,000 therapeutic units of platelets have been transfused in 2006. Currently, there are no mandatory national transfusion guidelines in Switzerland. The Blood Transfusion Service of the Swiss Red Cross Ltd (BTS SRC), a non-profit organisation, is in charge of the reference activities in immunohaemotology and serology, and issues the national guidelines that regulate the standards of quality and logistics for blood donations. Blood donations are collected exclusively from healthy non-remunerated voluntary blood donors mainly by 13 Regional Blood Transfusion Services (RBTS) throughout the country. Thereby, self-sufficient blood supply is achieved. In 2002, the federal Law on Therapeutic Products was enacted. The law set up a federal drug regulatory agency (Swissmedic) which is the competent authority for blood components. The decisions of Swissmedic are mandatory all over the country and guarantee the quality, safety, and efficiency in preparing and releasing blood components. RBTS and all hospitals performing blood transfusions must nominate a person in charge of haemovigilance who notifies all suspected adverse events to Swissmedic.

Data Collection and Analysis

All suspected adverse events have to be reported to Swissmedic using a standardised form. Reported events are categorised according to criteria defined in the annual national report of 2002/3 [1]. The collected data are analysed annually and summarised in a national haemovigilance report. For the current analysis of the cases of TRALI, the recent definition of the Consensus Conference of Toronto is applied [2]. Based on these data, the number of annually transfused blood components and international haemovigilance data, we estimated the possible degree of underreporting and the risk for significant adverse events.

Results

The reported suspected adverse transfusion events in 2005 and 2006 are sorted by declining incidence of categories and summarised in table table1.1. Bacterial contamination of platelet concentrates are included in the category of ‘Transfusion Transmitted Infections’. The 8 and 4 notifications of clinically significant bacterial contamination of platelet concentrates in 2005 and 2006, respectively, result in an estimated corresponding risk of transfusion transmitted bacterial infections of at least 1:2,500 to 1:5,000. The risk of administration of an incorrect blood product is estimated at 1:20,000 transfusions. Three and 8 cases of suspected TRALI were reported in 2005 and 2006, respectively, after administration of qFFP. Another 2 cases of TRALI were reported in 2006 after administration of red blood cells only. Since approximately 60,000 qFFP are administered in Switzerland annually, the risk of TRALI can be estimated at 1:8,000 to 1:20,000 after administration of 1 unit of qFFP.

Table 1
Number of reported suspected Transfusion Events in Switzerland by category

Discussion

As reported by Michlig et al. [3], an adverse transfusion event is expected after almost 5 of 1,000 transfusions. In comparison with the reported 1.5 and 2 suspected adverse transfusion events per 1,000 transfusions prescribed in Switzerland in 2005 and 2006, respectively, one can assume a significant underreporting.

Bacterial contamination of platelet concentrates, transfusion of an incorrect blood component and TRALI are considered to be the most serious adverse events [4, 5]. The estimated risks for transfusion of a bacterially contaminated platelet concentrate, TRALI due to plasma transfusion and transfusion of an incorrect blood component are 1:2,500 to 1:5,000, 1:8,000 to 1:20,000 and 1:20,000, respectively. For the period of 2002–2004, the risk of a transfusion transmitted viral infection was estimated at 1:2,300,000 for HIV, 1:2,200,0000 for HCV and 1:141,000 for HBV [6].

Consequently, we conclude that current haemovigilance data support the assumption that TRALI is a significant transfusion risk in Switzerland. Our analysis of TRALI data collected in Switzerland between January 2002 and November 2007 reveal that cases can be attributed to groups supporting both, the immunological hypothesis [7] and the two-hit model [8]. Among 25 reported cases, 4 are proven immune TRALI, 2 are highly likely immune TRALI, 10 are possibly immune TRALI, 8 are non-immune TRALI and 1 is a suspected case which could not be confirmed as TRALI. The cases are summarised in table table2.2. Seventeen of these cases were reported between 2002 and June 2006 and have already been published [9]. The additional 8 cases were reported to Swissmedic between June 2006 and November 2007. Based on the hypothesis of an immunological trigger of TRALI, an exclusion of the transfusion of plasma from female donors can be considered as a precautionary measure. The introduction of such a measure might have prevented 4 cases of proven immune TRALI, 2 cases of highly likely immune TRALI, and an unknown number of the 10 possibly immune TRALI, but would most likely have had no influence on the 8 non-immune TRALI cases.

Table 2
TRALI cases and their etiologie category

Prompted by the encouraging effects of comparable measures in other countries, in 2006 the BTS SRC managed a national study in order to determine whether the supply of qFFP could be reliably maintained by collecting plasma from male donors only. The study confirmed this assumption, given the fact that 80% of the required plasma for transfusion was covered by qFFP and 20% by SD-P. Provided that these proportions are maintained, the decision was made that starting January 1, 2007 the production of qFFP is restricted to donations from men or from women confirming that they have never been pregnant (to their knowledge) or with negative tests for antibodies against HLA class I and II. Plasma donated before the introduction of this measure may still be released for transfusion until the end of 2009. Therefore, our current haemovigilance data do not yet allow any conclusions on the efficacy of the measure introduced. In this context, it has to be mentioned that all persons who have been transfused after 1980 are already definitively deferred from donating blood since October 1, 2004, primarily as a precautionary measure to prevent the possible transmission of variant Creutzfeldt-Jakob disease (vCJD) through blood components.

References

1. Swissmedic: Hämovigilanz Bericht 2002/2003; www.swissmedic.ch/files/pdf/Haemovigilance_Jahresbericht_D.pdf.
2. Kleinman S, Caulfield T, Chan P, et al. Toward an understanding of transfusion-related acute lung injury: statement of a consensus panel. Transfusion. 2004;44:1774–89. [PubMed]
3. Michlig C, Vu D-H, Wasserfallen J-B, Spahn DR, Schneider P, Tissot J-D. Three years of hemovigilance in a general university hospital. Transfus Med. 2003;13:63–73. [PubMed]
4. SHOT Annual Report 2006, p. 13; www.shotuk.org/SHOT_report_2006.pdf.
5. Davis A, Mandal R, Johnson M, Makar R, Stowell C, Dzik S. A touch of TRALI. Transfusion. 2008;48:541–5. [PubMed]
6. Niederhauser C, Schneider P, Fopp M, Ruefer A, Lévy G. Incidence of viral markers and evaluation of the estimated risk in the Swiss blood donor population from 1996 to 2003. Euro Surveill. 2005;10:14–6. [PubMed]
7. Bux J, Sachs UJ. The pathogenesis of transfusion-related acute lung injury (TRALI) Br J Haematol. 2007;136:788–99. [PubMed]
8. Silliman C. The two-event model of transfusion-related acute lung injury. Crit Care Med. 2006;34:S124–31. [PubMed]
9. Senn M, Mansouri Taleghani B. International forum: measures to prevent TRALI. Vox Sang. 2007;92:258–277. [PubMed]

Articles from Transfusion Medicine and Hemotherapy are provided here courtesy of Karger Publishers