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)

Abstract

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 (DSTRs). 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 RBCs 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 (DATs) 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 DSTRs compared to 8 (7_3%) in the SCREEN group at the time of follow-up (P = 0_02). Overall, post-transfusion DATs 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 DSTRs. 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.