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French Haemovigilance Data on Platelet Transfusion
Béatrice Willaert1, Mai-Phuong Vo Mai, Cyril Caldani
1Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), Saint Denis, France.
Summary
Apheresis platelet concentrates (APC) show a higher incidence of transfusion reactions compared to pooled platelet concentrates (PP). This finding highlights the need for further investigation into preventive measures for APC transfusions.
Area of Science:
- Transfusion Medicine
- Hematology
- Patient Safety
Background:
- The French Health Products Safety Agency (Afssaps) manages the national hemovigilance network.
- Adverse transfusion reaction data is collected regardless of severity.
Purpose of the Study:
- To evaluate the safety and tolerance of pooled platelet concentrates (PP) versus apheresis platelet concentrates (APC).
- To compare transfusion incident rates between PP and APC.
Main Methods:
- Screening of the French national hemovigilance database from January 1, 2000, to December 31, 2006.
- Statistical analysis using the chi-square test to compare incident rates.
Main Results:
- Apheresis platelet concentrates (APC) had more than double the transfusion incident reports compared to pooled platelet concentrates (PP) (8.61 vs. 4.21 per 1,000 LBP).
- The difference in incident rates was statistically significant (chi-square test, p < 0.05).
- Allergic reactions were the most common adverse event associated with APC, occurring at a rate of 1 in 200 APC units issued, though rarely serious.
Conclusions:
- Apheresis platelet concentrates (APC) are associated with a higher risk of adverse transfusion reactions than pooled platelet concentrates (PP).
- Further evaluation is recommended, particularly concerning the impact of additive solutions used since 2005, to develop preventive strategies.
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