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

Jerrold H. Levy, Roque Pifarre, Hartzell V. Schaff, Jan C. Horrow, Robert Albus, Bruce Spiess, Todd K. Rosengart, Jeffrey Murray, Richard E. Clark, Peter Smith, Andrea Nadel, Sharon L. Bonney, Robert Kleinfield

Research output: Contribution to journalArticle

261 Scopus citations

Abstract

Background. 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. Methods and Results: 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). Conclusion. 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.

Original languageEnglish (US)
Pages (from-to)2236-2244
Number of pages9
JournalCirculation
Volume92
Issue number8
DOIs
StatePublished - Oct 15 1995

Keywords

  • aprotinin
  • bleeding
  • cardiopulmonary bypass
  • fibrinolysis
  • surgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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    Levy, J. H., Pifarre, R., Schaff, H. V., Horrow, J. C., Albus, R., Spiess, B., Rosengart, T. K., Murray, J., Clark, R. E., Smith, P., Nadel, A., Bonney, S. L., & Kleinfield, R. (1995). 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. Circulation, 92(8), 2236-2244. https://doi.org/10.1161/01.CIR.92.8.2236