A ten-year hemovigilance report in the regional blood transfusion center of Sfax (Tunisia).

Abstract

Objectives: In Tunisia, despite hemovigilance regulations since 2007, transfusion adverse events (TAEs) remain underreported. Here, we analyze and evaluate the reported TAEs over ten years in the blood transfusion center of Sfax (Tunisia).

Methods: This is a ten-year (2012-2021) descriptive and exhaustive report on TAE from the second largest blood center in Tunisia, where around 56,000 labile blood products are issued annually.

Results: Four-hundred-sixty-four TAEs were reported. The median age of the patients was 38 years (1 month to 94 years). The sex ratio was 0.68. The overall TAE annual incidence per issued labile blood product was 0.77‰ and ranged from 0.47 to 1.43‰. The most common TAE was a febrile non-hemolytic reaction (31.7%), followed by an allergic reaction (21.6%). The severity degree was informed in 433 cases (93.3%). Grade 1 severity was the most common (80.8%), followed by grades 3, 2 and 4 (10.6%, 1.3% and 0.6%, respectively). Packed red blood cells were the most implicated labile blood product (81.5%). Standard platelet concentrates and fresh frozen plasma accounted for 6.5% and 5% of the total adverse transfusion reactions, respectively.

Conclusion: The TAE incidence in our study seems to be underestimated compared to worldwide reported TAEs. The analysis of reported TAEs in our context illustrates the insufficiency of the regulation's implementation alone.