Amustaline/glutathione pathogen-reduced red cell hemoglobin utilization in complex cardiac surgery: A post hoc analysis of the phase 3 ReCePI trial.

BACKGROUND: The ReCePI randomized, controlled trial compared amustaline/glutathione pathogen-reduced (PR) and conventional red blood cell (RBC) transfusions in cardiac surgery. STUDY DESIGN AND METHODS: We performed a post-hoc analysis of hemoglobin (Hb) utilization and safety outcomes. Hb content of study RBCs was measured at manufacture. Subject Hb levels, estimated blood loss and blood product use were recorded during and for 7 days post-surgery. Acute kidney injury (AKI) incidence was graded over 7 days, and adverse events were assessed for 28 days. RESULTS: PR-RBCs contained 5.2% less Hb (mean [SD] Test 58.1 [6.5] g; Control 61.5 [6.8] g Hb, p < .001) due to manufacturing volume losses. Four hundred fifty-six PR- and 524 conventional RBCs were transfused to 159 Test and 162 Control subjects, respectively. Mean subject baseline and post-surgery Hb levels, and blood loss were not different between groups. Test subjects tended to require fewer total RBCs (3.5 [2.7] Test vs. 4.0 [3.5] Control, p = .08) resulting in 17.6% significantly less mean total Hb transfused (Test 203.2 g; Control 246.8 g Hb, p = .01). The proportions of subjects transfused with, and the number of platelet and cryoprecipitate units transfused were not different. Test subjects received less plasma (2.3 [1.8] units Test vs. 3.5 [3.8] Control, p = .03). Overall incidence of adverse events and AKI were not clinically different. Imbalances in AKI severity (Grade III Test 15/159 [9.4%]; Control 7/162 [4.3%], p = .07) may suggest under-transfusion in the highest-risk Test subjects. DISCUSSION: Test patients required less transfused Hb than control subjects to maintain equivalent daily hemoglobin levels following similar blood loss.

Duke Scholars

Author Ian James Welsby Anesthesiology, Cardiothoracic