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

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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
StatePublished - Oct 15 1995

Fingerprint

Aprotinin
Coronary Artery Bypass
Blood Transfusion
Placebos
Tissue Donors
Myocardial Infarction
Transplants
Erythrocyte Transfusion
Serine Proteinase Inhibitors
Drainage

Keywords

  • aprotinin
  • bleeding
  • cardiopulmonary bypass
  • fibrinolysis
  • surgery

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

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

In: Circulation, Vol. 92, No. 8, 15.10.1995, p. 2236-2244.

Research output: Contribution to journalArticle

Levy, JH, Pifarre, R, Schaff, HV, Horrow, JC, Albus, R, Spiess, B, Rosengart, TK, Murray, J, Clark, RE, Smith, P, Nadel, A, Bonney, SL & 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, vol. 92, no. 8, pp. 2236-2244.
Levy, Jerrold H. ; Pifarre, Roque ; Schaff, Hartzell V ; Horrow, Jan C. ; Albus, Robert ; Spiess, Bruce ; Rosengart, Todd K. ; Murray, Jeffrey ; Clark, Richard E. ; Smith, Peter ; Nadel, Andrea ; Bonney, Sharon L. ; Kleinfield, Robert. / 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. In: Circulation. 1995 ; Vol. 92, No. 8. pp. 2236-2244.
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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.",
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AU - Pifarre, Roque

AU - Schaff, Hartzell V

AU - Horrow, Jan C.

AU - Albus, Robert

AU - Spiess, Bruce

AU - Rosengart, Todd K.

AU - Murray, Jeffrey

AU - Clark, Richard E.

AU - Smith, Peter

AU - Nadel, Andrea

AU - Bonney, Sharon L.

AU - Kleinfield, Robert

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N2 - 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.

AB - 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.

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