Hemovigilance: Clinical Tolerance of Solvent-Detergent Treated Plasma

OBJECTIVE: This study was conducted to assess retrospectively the clinical tolerance of SD treated plasma and to compare it to other labile blood products (red blood cell and platelet concentrates). METHODS: Adverse events (AEs) related to the use of blood products at the Blood Transfusion Center (BTC) are routinely collected through a formalised system of hemovigilance. All AEs reported are entered into a safety data base which was used for the study. All AEs reported during a one-year period to the BTC were retrospectively re-assessed and descriptive statistics calculated. RESULTS: 5064 units of SD treated plasma were transfused to 894 recipients during the study period at the occasion of 1553 transfusions. No AE associated to SD treatment plasma was reported during that period. In contrast, during the same period, 485 AEs associated with the use of red blood cell concentrates (RBCC) were reported in 251 patients at the occasion of 262 transfusions. 2.1% (251/11,748) of the patients transfused with RBCC experienced one or more AEs. The incidence of AEs per unit transfused was 1.3% (485/37,332), and 2.4% (485/20,460) of RBCC transfusions were associated with one or more AEs. 142 AEs associated with the use of platelet concentrate (PC) were observed in 69 patients at the occasion of 73 transfusions. 4.2% (69/1645) of patients transfused with PC experienced one or more AEs. The incidence of AEs per unit transfused was 1.1% (142/12,772), and 2.8% (142/5034) of PC transfusions were associated with one or more AEs. All reported AEs were classified and non serious. The most frequently observed AEs were fever, chills and rashes which accounted for roughly 64% of all reported AEs. CONCLUSION: As for the overall clinical tolerance of red cell and platelet concentrates, the results of this study are in complete agreement with the published literature. The study also confirms the extremely good tolerability of SD treated plasma in comparison with other labile blood products.