APROTININ IN PRIMARY VALVE-REPLACEMENT END RECONSTRUCTION - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Background: Patients having cardiac operations often require blood tra nsfusions, Aprotinin reduces the need for blood transfusions during co ronary artery bypass graft operations. To determine the safety and eff ectiveness of aprotinin in reducing the use of allogeneic blood and po stoperative mediastinal chest tube drainage, we studied 212 patients u ndergoing primary sternotomy for valve replacement or repair, Methods: This study was multicenter, randomized, prospective, double-blind, an d placebo-controlled, Patients received high-dose aprotinin (n = 71), low-dose aprotinin (n = 70), or placebo (n = 71), The study medication was given as a loading dose followed by a continuous infusion and pum p prime dose. Heparin administration was standardized, Transfusions, p ostoperative mediastinal shed blood, and adverse events were tracked, Results: Demographic profiles were similar among the treatment groups, Aprotinin did not decrease the percentage of patients receiving trans fusions when compared with placebo (high-dose aprotinin, 63%, p = 0.09 2; low-dose aprotinin, 52%, p = 0.592; placebo, 48%), Aprotinin was as sociated with a reduction in the volume of mediastinal shed blood (hig h-dose aprotinin vs placebo, p = 0.002; low-dose aprotinin vs placebo, p = 0.017), Adverse events were equally distributed among the treatme nt groups except for postoperative renal dysfunction (high-dose aproti nin, 11%; low-dose aprotinin, 7%; placebo, 0%; p = 0.01), A disproport ionate number of patients in the high-dose aprotinin group with postop erative renal dysfunction also had diabetes mellitus, Conclusions: Apr otinin treatment in this population did not reduce allogeneic blood us e, although there were significant reductions in the volume of mediast inal shed blood.