The role of improved pre‐transfusion testing in the prevention of delayed serologic transfusion reactions among blood recipients in Uganda: a Randomized Controlled Trial ( IPAT Study)

Background and objectives The goal of pre‐transfusion testing ( PTT ) is to provide patients with beneficial and safe transfusions. In Uganda, PTT includes ABO /RhD typing plus room temperature ( RT ) saline cross‐matches without red‐blood‐cell ( RBC ) alloantibody screening. The aim of the IPAT study was to assess the role of improved PTT in the prevention of delayed serologic transfusion reactions ( DSTR s). Materials and methods In this randomized controlled trial, patients at Mbarara Hospital in Uganda, with a history of RBC exposure, were randomized 1:1 to have either RBC alloantibody screening ( SCREEN group) or room temperature saline cross‐matches ( CONTROL group) during PTT . ‘Home‐made’ reagent RBC s from group O RhD‐positive volunteers were used for antibody screening in the indirect antiglobulin test. Participants were evaluated for RBC alloantibody production 7–14 days after transfusion. Post‐transfusion haemoglobin estimation and direct antiglobulin tests ( DAT s) were also performed. Results We randomized 220 patients to either the SCREEN or CONTROL group. Both study arms had similar demographic and transfusion characteristics at baseline. There were 19 (17·3%) individuals in the CONTROL group with DSTR s compared to 8 (7·3%) in the SCREEN group at the time of follow‐up ( P = 0·02). Overall, post‐transfusion DAT s were positive in 7 (3·5%) patients but there was no associated decrease in haemoglobin levels. Conclusion Red‐blood‐cell alloantibody screening is associated with occurrence of significantly fewer DSTR s. The use of ‘home‐made’ reagent cells during PTT in Uganda is feasible. We recommend a change in the local PTT policy to consider the introduction of RBC alloantibody screening.