title: Efficacy and safety of aprotinin in aortocoronary bypass and valve replacement operations: a placebo-controlled randomized double-blind study.
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 x 10(5) Kallikrein Inactivating Units (KIU) of aprotinin before incision, 2 x 10(6) KIU in the priming solution and 5 x 10(5) 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.
authors.affiliation: Department of Cardiac Surgery, University Hospital of Antwerp, Edegem, Belgium.
authors.forename: I E
authors.initials: IE
authors.lastname: Rodrigus
authors.forename: K M
authors.initials: KM
authors.lastname: Vermeyen
authors.forename: S G
authors.initials: SG
authors.lastname: De Hert
authors.forename: B J
authors.initials: BJ
authors.lastname: Amsel
authors.forename: P J
authors.initials: PJ
authors.lastname: Walter
mesh_terms: D000328:Adult; D000368:Aged; D007611:Aprotinin / Q000009:adverse effects / Q000627:therapeutic use*; D002315:Cardiopulmonary Bypass; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D005260:Female; D006351:Heart Valves / Q000601:surgery*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control*
chemical_list: D006490:Hemostatics; D007611:Aprotinin