APROTININ

OBJECTIVE: To review the clinical pharmacology of aprotinin in patient s undergoing surgical procedures involving major blood loss, namely, c oronary artery bypass graft (CABG). DATA SOURCES: A MEDLINE search was used to identify French- and English-language publications on aprotin in using the indexing terms aprotinin, cardiothoracic surgery, and hem orrhage. The MEDLINE search was supplemented by review of article bibl iographies. Data also were obtained from the approved Canadian and US product labels. STUDY SELECTIONS: All abstracts and uncontrolled and c ontrolled clinical trials were reviewed. DATA EXTRACTION: Study design , population, results, and safety information were retained. Efficacy conclusions were drawn from controlled trials. DATA SYNTHESIS: Aprotin in, a serine protease inhibitor isolated from bovine lung tissue, decr eases bleeding after cardiac surgery by mechanisms including antifibri nolytic activity and preservation of platelet function. Several trials have shown that aprotinin reduced blood loss and transfusion requirem ents in patients undergoing CABG. Its use in other surgical procedures involving major blood loss has been reported. Aprotinin is well toler ated, with minor allergic reactions being the most frequently reported adverse effect Although unsubstantiated, the possibility that aprotin in could create a prothrombic state leading to early graft occlusion a nd formation of microthrombi in renal and coronary vasculatures is of concern. CONCLUSIONS: Aprotinin is an effective hemostatic agent in CA BG. Clear definitions of indications, dosing, safety, and repeated use remain to be investigated thoroughly.