The German Haemovigilance System–reports of serious adverse transfusion reactions between 1997 and 2007

Abstract

Data of the German Haemovigilance System were collected from 1997 to 2007 and assessed on the basis of pre-defined safety standards. Suspected cases of serious adverse reactions following transfusions reported to the Paul-Ehrlich-Institut were evaluated on the basis of national criteria, and the definitions of International Society of Blood Transfusion (ISBT) in compliance with defined causality criteria. The suspected cases were rated as confirmed and unconfirmed transfusion reactions. Assessment of causality took into consideration the clinical course of the adverse reaction and, if necessary, information about donation and manufacturing. Of the 5128 suspected serious adverse reactions, 1603 could be confirmed. Referring to the absolute figures, acute transfusion reactions (e.g. allergic reactions, hypotension and dyspnoea) were recorded most frequently, followed by transfusion-related acute lung injury (TRALI), haemolytic reactions, transfusion-related bacterial infections and virus infections. The majority of the 52 transfusion-related fatalities (14 each) were due to TRALI and acute transfusion reactions (mostly severe allergic reactions). Referred to the blood products administered, immune TRALI cases and TRALI-related fatal courses were most frequently reported after administration of fresh frozen plasma (FFP) (15/10(6) and 3.5/10(6) units, respectively), transfusion-related bacterial infections after administration of platelet concentrates (7/10(6) units), acute haemolytic transfusion reactions after administration of red blood cell concentrates (2.3/10(6)units) and acute transfusion reactions after administration of red blood cell or platelet concentrates (7.8/10(6) and 13/10(6) units, respectively). Despite the high safety standard required for blood products in Germany, there is still room for reducing the frequency of isolated cases of transfusion reactions by targeted action.

Hemovigilância: a experiência da notificação de reações transfusionais em Hospital Universitário

“…When data from NOTIVISA recorded between 2007 and 2015 are analyzed separately, we see that FNHTR and allergic reactions are more prevalent in SNH, with incidence rates of 49% and 37.3%, respectively (6) . Although severe reactions result in greater morbidity, they were not thoroughly analyzed, similarly to other studies (16,22) , which described most reactions as being of first degree (mild). However, in another study (11) , most adverse reactions did not present any risk of mortality to patients.…”

“…Among those of greater morbidity were TRALI at 9.5% (2/21) and AHTR at 4.8% (1/21) (8,10,14) . TRALI, which is a severe reaction, is not frequently reported by services and this leads some authors to suggest the occurrence of underreporting as a result of the lack of preparation or knowledge within these services (16,(22)(23) . In a study conducted in Norway, the authors state that such reaction rarely occurs (20) , whereas in a study conducted in Germany TRALI was the most common cause of death related to transfusion reaction (22) .…”

“…TRALI, which is a severe reaction, is not frequently reported by services and this leads some authors to suggest the occurrence of underreporting as a result of the lack of preparation or knowledge within these services (16,(22)(23) . In a study conducted in Norway, the authors state that such reaction rarely occurs (20) , whereas in a study conducted in Germany TRALI was the most common cause of death related to transfusion reaction (22) . The profile of data reported by Hospital São Paulo, where 99% of immediate reactions were observed (24) , is similar to those of NOTIVISA (6) (97%) and of the state of São Paulo (99.9%) (23) .…”

Kritik çocuk hastalarda akut transfüzyon reaksiyonları

“…‹laçlardan farkl› olarak kan ürün-lerinin gerekçeleri ve güvenilirlikleri konusunda yeterli veri yoktur. Kan ürünü transfüzyonu iliflkili reaksiyonlar hayat› tehdit edebilir (3)(4)(5). Transfüzyona ba¤l› reaksiyonlar uygulamadan hemen sonra veya günler içinde geliflebilir.…”

“…Akut transfüzyon reaksiyonlar› (ATR) uygulamadan sonraki ilk 24 saat içinde s›kl›kla ilk dört saat içinde geliflen reaksiyonlar› tan›mlamakta kullan›l›r (6,7). Akut transfüzyon reaksiyonlar› kullan›lan kan ve kan ürünü, uygulanan hasta grubu ve yaflla ba¤lant›l› olarak de¤iflebilmektedir (4,5,7). Çocuklarda ATR s›kl›¤› ve tipleri ile ilgili yeterli veri yoktur.…”