French haemovigilance data on adverse reactions related to platelet transfusion

Afssaps

Description

Blood and blood products
04/05/2009

Informations

• Publié par: ansm-blood-and-blood-products
• Publié le: 04 mai 2009
• Nombre de lectures: 16
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

French haemovigilance data on adverse reactions related to platelet transfusion

Béatrice WiLLAeRT, Mai-Phuong VO MAi, Cyril CALdANi, Nadra OuNOugheNNe, imad sANdid haemovigilance unit of The French health Products safety Agency (Afssaps)

BAcKGround And oBJEctIVE The French health Products safety Agency (Afssaps) is respon - sible through its haemovigilance unit, for the organization and the functioning of the national haemovigilance network for more than 14 years; haemovigilance has aimed to prevent the occurrence of adverse reactions related to the transfusion of labile blood products (LBP).

in accordance with the French law, the haemovigilance unit receives all data on adverse transfusion reactions regardless of their severity. in France, we use five imputability levels and five levels of severity (fig. 1, 2).

frEnch dEfInItIonS of SEVErIty Transfusion of inappropriate LBP to the p tient, without any measurable   a GrAdE 0 biologic or clinical effect Absence of immediate GrAdE 1 or long-term vital threat   -t GrAdE 2 long erm « morbidity »   immediate vital threat GrAdE 3   death GrAdE 4   Figure 1

frEnch dEfInItIonS of IMPutABILIty excluded IMPutABILIty 0   unlike IMPutABILIty 1 ly   Possible IMPutABILIty 2   Likely IMPutABILIty 3   Certain IMPutABILIty 4   Figure 2 From 1995 to 2006, about 32.074.000 LBP were transfused and 85.700 adverse reactions associated with transfusion were registered. until 1999, the AR/LBP rate had increased, and then had remained stable between 2,8 and 3/1000. so our results are presented from 2000. On average we have received 7.600 notifications of adverse reactions per annum; among them more than 72,4 % were of minor severity (grade 1)(fig. 3).

tIME SErIES Ar 1995-2006

Cumulative data 1995-2006 8 000

7 000

6 000 5 000

4 000

3 000

Overall notifications

Imputability >= 2

2 000 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Figure 3

in order, in particular, to reduce the residual viral risk of transfusion of platelet (lower exposure to blood donations), platelets issued from 2000 to 2006 are more often apheresis platelet concentrates (APC) 85,6% than pooled platelet (PP) 14,4%.

since 1995, the amount of APC used in France has increased regularly until 2006: from 130.000 APC to 190.000 APC, instead PP has decreased from 72.000 to 24.000 in 2002. From then, it has increased up to 43.000 in 2006.

2870é ëçÉíê01ñ10.85áåÇÇ 2

MEthodS And dAtA The present study aimed to assess the tolerance of these two kinds of LBP in terms of adverse reactions (AR) observed in recipients. We therefore screened the database of the national haemovigilance network that gives an exhaustive view of the AR notifications in France in combination with a complete traceability of the transfused LBP for AR possibly, likely or certainly attributable to the transfusion of these two types of platelets concentrates (PC) between January 1 st , 2000 and december 31, 2006. rESuLtS All the notifications of adverse reactions (French imputability levels 2, 3, 4) from 2000 to 2006 were reported to blood products issued. We observed that the number of AR (adverse reaction reported) attributed to 1000 LBP is more than twice superior with APC (8,61 p 1000) than with PP (4,21 p 1000). The difference between these two rates is statistically significant according to chi-square analysis (e=21, 00 withα= 5 %) (fig. 4). notIfIcAtIon, IMPutABILIty >=2 coMPLEtE InVEStIGAtIon, 2000-2006 Ar/1000 LBP Ar grade4/100000LBP LBP LBP issued 2000-2006 2000-2006 RBCC 14098804 1,85 0,50 APC 1251391 8,61 1,84 PP(MCP) 210628 4,21 0,95 PLAsMA 1896460 0,50 0,05 Figure 4 For the period 2000-2006, focus has been put on major type of diagnosis related to APC and PP transfusion. 10.025 allergic reactions were reported of with 6.258 were associated with APC transfusion. The risk of allergy is 1 per 200 issued APC (1/630 for pooled platelet) (fig. 5). notIfIcAtIon of AdVErSE rEActIonS, IMPutABILIty >=2 coMPLEtE InVEStIGAtIon, 2000-2006 Ar/1000 APc Ar /1000PP FNhTR 1,617 0,883 ALLeRgY 5,001 1,595 ALLO-iMMuNisATiON 0,292 0,864 uNkNOWN 0,797 0,351 iMMuNOLOgiC iNCOMPATiBiLiTY 0,391 0,370 TRANsFusiON uNeFFiCieNCY 0,244 0,062 TACO 0,062 0,024 ViRus iNFeCTiON 0,002 0,000 OTheR iMMediATAR 0,121 0,009 TTBi 0,037 0,033 TRALi 0,033 0,005 OTheR deLAYed AR 0,015 0,000 ALLAr 8,612 4,211 deATh 0,018 0,009 Figure 5 during the period from 2000 to 2006, it is with aphaeresis platelet concentrate that we observed the most adverse reactions, even though often minor adverse reactions (93%). The risk is higher with APC for all adverse reactions except alloimmunization (fig. 6).

notIfIcAtIon of AdVErSE rEActIonS IMPutABILIty >=2 coMPLEtE InVEStIGAtIon, 2000-2006 Ratio of TIR for 1000 products - imputability >=2, 2000-200 6 10,00

8,00

6,00

4,00

2,00

0,00

2000

2001

APC

MCP

All products RBC PLASMA 2002 2003

2004

2005

2006

Figure 6

concLuSIon The data of the French haemovigilance show that APC transfusion appears to be the greatest “allergy” type reaction risk factor even if it should be remembered that allergic reactions are rarely serious and only APC allows HLA- compatible platelet concentrates. Since 2005, a slight decrease in the number of notified allergic reactions has been observed with apheresis platelet concentrate. The impact of platelet additive solutions should be evaluated with the benefit of hindsight. The French national haemovigilance commission had created a working group on the topic of allergy.