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

Ovid Technologies (Wolters Kluwer Health) - Tập 92 Số 8 - Trang 2236-2244 - 1995
Jerrold H. Levy1, Roque Pifarré1, Hartzell V. Schaff1, Jan C. Horrow1, Robert A. Albus1, Bruce D. Spiess1, Todd K. Rosengart1, Jeff Murray1, Richard E. Clark1, Peter K. Smith1, Andrea Nadel1, Sharon L. Bonney1, Robert Kleinfield1
1From the Department of Anesthesiology, Emory University Hospital, Atlanta, Ga (J.H.L.); the Department of Thoracic and Cardiovascular Surgery, Loyola University Medical Center, Maywood, Ill (R.P.); the Section of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn (H.V.S.); the Department of Anesthesiology, Hahnemann University, Philadelphia, Pa (J.C.H.); Virginia Heart Surgery Associates, Fairfax (R.A.); the Department of Anesthesiology, University of Washington Medical Center, Seattle (B.S.); the...

Tóm tắt

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). Conclusions 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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Tài liệu tham khảo

10.1056/NEJM198605293142209

10.1055/s-2007-1004382

Harker LA, Malpass TW, Branson HE, Hessel EA II, Slichter SJ. Mechanism of abnormal bleeding in patients undergoing cardiopulmonary bypass: acquired transient platelet dysfunction associated with selective alpha-granule release. Blood. 1980;56:824-834.

10.1182/blood.V76.9.1680.1680

10.2165/00003495-198529030-00003

10.1016/S0022-5223(19)35778-2

10.1056/NEJM198605293142202

10.1161/circ.77.6.3286039

10.1056/NEJM198911233212104

10.1016/S0022-5223(19)36060-X

10.1016/S0022-5223(19)35634-X

10.1111/j.1365-2141.1981.tb07244.x

10.1016/1053-0770(91)90052-U

10.1016/0003-4975(93)90149-C

10.1016/S0022-5223(19)36611-5

10.1016/S0022-5223(19)36893-X

10.1016/S0003-4975(10)62153-4

10.1016/S0022-5223(19)35496-0

10.1016/S0140-6736(87)91190-1

10.1016/S0022-5223(19)34573-8

10.1097/00000542-199012000-00009

10.1016/0003-4975(91)91009-K

10.1016/1053-0770(92)90150-6

10.1016/0003-4975(93)90128-5

10.1055/s-2007-1013915

10.1016/S0022-5223(19)33859-0

10.1016/0003-4975(92)90066-D

10.1016/0003-4975(92)90089-M

10.1016/0003-4975(93)90035-G

Isetta C Samat C Jourdan J Grimaud D. Aprotinin treatment in cardiac surgery: low dose versus high dose. Anesthesiology. 1992;77(suppl):A139. Abstract.

10.1016/S0022-5223(19)36879-5

10.1007/BF03009699

10.1055/s-2007-1013813

Hunt BJ Segal H Yacoub M. Monitoring heparin by the activated clotting time when aprotinin is used during cardiopulmonary bypass. Thromb Haemost. 1991;65(suppl):1025. Abstract.

10.1097/00001721-199304010-00007

10.1016/S0022-5223(19)34702-6

10.1097/00000542-199212000-00006

10.1161/circ.21.6.1160

10.1016/S0022-5223(19)39064-6

10.3109/14017438509102816

Hutter JA, Aps C, Hemsi D, Williams BY. The management of cardiac surgical patients in a general surgical recovery ward. J Cardiovasc Surg (Torino). 1989;30:273-276.

10.1056/NEJM199208063270610

Murray DJ, Gress K, Weinstein SL. Homologous transfusion is associated with post-operative infection in coronary bypass patients. Ann Clin Lab Sci. 1992;22:260. Abstract.

10.1056/NEJM199208063270601

10.1007/BF01658455

10.1200/JCO.1991.9.10.1889

10.1016/S0022-5223(19)34696-3

Smith DM Jr Dodd RY. Transfusion-Transmitted Infections. Chicago Ill: American Society of Clinical Pathologists; 1991:9-10.

10.1016/S0003-4975(10)63778-2

10.1016/S0003-4975(10)60113-0

10.1016/0003-4975(91)90305-A

10.1016/S0022-5223(94)70101-6

10.1016/S0022-5223(12)70102-2

10.1016/S0022-5223(94)70336-1

Royston D Bidstrup BP Taylor KM Sapsford RN. Reduced blood loss following open heart surgery with aprotinin (Trasylol) is associated with an increase in intraoperative activated clotting time. J Cardiothorac Vasc Anesth. 1989;3(suppl 1):80. Abstract.

10.1016/0003-4975(93)90272-J

Kramer HJ, Dusing R, Glanzer K, Kipnowski J, Klingmuller D, Meyer-Lehnert H. Effect of aprotinin on renal function. Contrib Nephrol. 1984;42:233-241.

10.1161/01.hyp.5.6.893

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Ovid Technologies (Wolters Kluwer Health)

Tập 92 Số 8

2236-2244

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