Efficacy and safety of aprotinin in aortocoronary bypass and valve replacement operations: a placebo-controlled randomized double-blind study

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Abstract
To assess the efficacy and safety of the use of a high-dose regimen of aprotinin in routine cardiac operations, a placebo-controlled randomized double- blind study was conducted in 93 adult patients undergoing cardiopulmonary bypass. Aprotinin-treated patients (group A, n = 46) received 2 × 106 Kallikrein Inactivating Units (KIU) of aprotinin before incision, 2 × 106 KIU in the priming solution and 5 x 105 KIU/h during CPB. Control patients (group B, n = 47) received the same volume of normal saline. Mean postoperative blood loss in ml after six hours and in total until removal of thoracic drains decreased significantly from 752 and 1933 in controls, to 358 and 1051 in treated patients ( p < 0.001). Mean total transfusion needs were 2.6 (A) and 4.8 (B) units per patient. Adverse events were evenly distributed between both groups and could not be attributed to aprotinin use. We, therefore, recommend the use of a high-dose regimen of aprotinin for routine cardiac operations despite its cost.