A multicenter, double-blind, placebo-controlled trial of aprotinin for reducing blood loss and the requirement for donor-blood transfusion in patients undergoing repeat coronary artery bypass grafting

Aprotinin is a serine protease inhibitor that reduces blood loss and transfusion requirements when administered prophylactically to cardiac surgical patients. To examine the safety and dose-related efficacy of aprotinin, a prospective, multicenter, placebo-controlled trial was conducted in patients...

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Bibliographic Details
Published in:Circulation (New York, N.Y.) N.Y.), 1995-10, Vol.92 (8), p.2236-2244
Main Authors: LEVY, J. H, PIFARRE, R, NADEL, A, BONNEY, S. L, KLEINFIELD, R, SCHAFF, H. V, HORROW, J. C, ALBUS, R, SPIESS, B, ROSENGART, T. K, MURRAY, J, CLARK, R. E, SMITH, P
Format: Article
Language:English
Subjects:
Aged
Aprotinin - administration & dosage
Aprotinin - adverse effects
Biological and medical sciences
Blood Loss, Surgical - prevention & control
Blood Transfusion
Blood Volume
Blood. Blood coagulation. Reticuloendothelial system
Coronary Artery Bypass
Dose-Response Relationship, Drug
Double-Blind Method
Female
Hemostatics - administration & dosage
Hemostatics - adverse effects
Humans
Incidence
Male
Medical sciences
Middle Aged
Myocardial Infarction - epidemiology
Pharmacology. Drug treatments
Postoperative Complications - epidemiology
Prospective Studies
Renal Insufficiency - epidemiology
Reoperation
Risk Factors
Serine Proteinase Inhibitors - administration & dosage
Serine Proteinase Inhibitors - adverse effects
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Summary:Aprotinin is a serine protease inhibitor that reduces blood loss and transfusion requirements when administered prophylactically to cardiac surgical patients. To examine the safety and dose-related efficacy of aprotinin, a prospective, multicenter, placebo-controlled trial was conducted in patients undergoing repeat coronary artery bypass graft (CABG) surgery. Two hundred eighty-seven patients were randomly assigned to receive either high-dose aprotinin, low-dose aprotinin, pump-prime-only aprotinin, or placebo. Drug efficacy was determined by the reduction in donor-blood transfusion up to postoperative day 12 and in postoperative thoracic-drainage volume. The percentage of patients requiring donor-red-blood-cell (RBC) transfusions in the high- and low-dose aprotinin groups was reduced compared with the pump-prime-only and placebo groups (high-dose aprotinin, 54%; low-dose aprotinin, 46%; pump-prime only, 72%; and placebo, 75%; overall P = .001). The number of units of donor RBCs transfused was significantly lower in the aprotinin-treated patients compared with placebo (high-dose aprotinin, 1.6 +/- 0.2 U; low-dose aprotinin, 1.6 +/- 0.3 U; pump-prime-only, 2.5 +/- 0.3 U; and placebo, 3.4 +/- 0.5 U; P = .0001). There was also a significant difference in total blood-product exposures among treatment groups (high-dose aprotinin, 2.2 +/- 0.4 U; low-dose aprotinin, 3.4 +/- 0.9 U; pump-prime-only, 5.1 +/- 0.9 U; placebo, 10.3 +/- 1.4 U). There were no differences among treatment groups for the incidence of perioperative myocardial infarction (MI). This study demonstrates that high- and low-dose aprotinin significantly reduces the requirement for donor-blood transfusion in repeat CABG patients without increasing the risk for perioperative MI.
ISSN:0009-7322
1524-4539
DOI:10.1161/01.CIR.92.8.2236