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Aprotinin Decreases Exposure to Allogeneic Blood During Primary Unilateral Total Hip Replacement*
J. M. Murkin, M.D.†; G. M. Haig, Pharm.D.‡; K. J. Beer, M.D.‡; N. Cicutti§, Ph.D.; J. McCutchen, M.D.#; M. E. Comunale, M.D.**; R. Hall, M.D.††; B. B. Ruzicka, Ph.D.‡‡
View Disclosures and Other Information
*One or more of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. Funds were received in total or partial support of the research or clinical study presented in this article. The funding source was Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut. The data in the present study was derived from protocol D95-006 sponsored by Bayer Corporation, Pharmaceutical Division.
†Department of Anaesthesia, London Health Sciences Center-UC, University of Western Ontario, 339 Windermere Road, London, Ontario N6A 5A5, Canada.
‡The Toledo Hospital, 2142 North Cove Boulevard, Toledo, Ohio 43606.
§The Ottawa Hospital, 1053 Carling Avenue, Ottawa, Ontario K1Y 4E9, Canada.
#Jewett Orthopaedic Clinic, 1285 Orange Avenue, Winter Park, Florida 32789.
**Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, Masschusetts 02215.
††Queen Elizabeth II Health Sciences Centre, 1796 Summer Street, Halifax, Nova Scotia B3H 3A7, Canada.
‡‡Bayer Corporation, 400 Morgan Lane, West Haven, Connecticut 06516.

J Bone Joint Surg Am, 2000 May 01;82(5):675-675
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Abstract

Background: Aprotinin, a hemostatic agent, regulates fibrinolysis, modulates the intrinsic coagulation pathway, stabilizes platelet function, and exhibits anti-inflammatory properties through inhibition of serine proteases, such as trypsin, plasmin, and kallikrein. Aprotinin has been used successfully for many years in cardiac operations, and there have been preliminary investigations of its use in hip replacement operations. The objectives of this multicenter, randomized, placebo-controlled, double-blind trial were to evaluate the efficacy and safety of aprotinin as a blood-sparing agent in patients undergoing an elective primary unilateral total hip replacement and to examine its effect on the prevalence of deep-vein thrombosis in this population.

Methods: Seventy-three patients received a placebo; seventy-six patients, a low dose of aprotinin (a load of 500,000 kallikrein inhibitor units [KIU]); seventy-five, a medium dose of aprotinin (a load of 1,000,000 KIU, with infusion of 250,000 KIU per hour); and seventy-seven patients, a high dose of aprotinin (a load of 2,000,000 KIU, with infusion of 500,000 KIU per hour). The end points for the determination of efficacy were transfusion requirements and blood loss. Patients received standard prophylaxis against deep-vein thrombosis and underwent compression ultrasonography with color Doppler imaging of the proximal and distal venous systems of both legs to evaluate for the presence of deep-vein thrombosis.

Results: Aprotinin reduced the percentages of patients who required any form of blood transfusion (47 percent of the patients managed with a placebo needed a transfusion compared with 28 percent of those managed with low-dose aprotinin [p = 0.02], 27 percent of those managed with high-dose aprotinin [p = 0.008], and 40 percent of those managed with medium-dose aprotinin [p = 0.5]). Only 6 percent (twelve) of the 212 patients treated with aprotinin required allogeneic blood compared with 15 percent (ten) of the sixty-eight patients treated with the placebo (p = 0.03). Aprotinin decreased the estimated intraoperative blood loss (p = 0.02 for the low-dose group, p = 0.04 for the medium-dose group, and p = 0.1 for the high-dose group), the measured postoperative drainage volume (p = 0.4 for the low-dose group, p = 0.006 for the medium-dose group, and p = 0.000 for the high-dose group), and the mean reduction in the hemoglobin level on the second postoperative day (thirty-four grams per liter for the placebo group, twenty-eight grams per liter for the low-dose group [p = 0.000], twenty-six grams per liter for the medium-dose group [p = 0.000], and twenty-three grams per liter for the high-dose group [p = 0.000]). The rate of deep-vein thrombosis was similar for all groups.

Conclusions: We concluded that aprotinin is safe and effective for use as a hemostatic agent in primary unilateral total hip replacements. In patients who are at high risk of receiving allogeneic blood, use of aprotinin may be of particular clinical and economic benefit.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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