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Aprotinin versus placebo in major orthopedic surgery: a randomized, double-blinded, dose-ranging study.

Author(s): Samama CM, Langeron O, Rosencher N, Capdevila X, Rouche P, Pegoix M, Berniere J, Coriat P

Affiliation(s): Departement d'Anesthesie-Reanimation, Centre Hospitalo-Universitaire (CHU) Avicenne, Bobigny, France. cmsamama@invivo.edu

Publication date & source: 2002-08, Anesth Analg., 95(2):287-93, table of contents.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

We conducted a prospective, multicenter, double-blinded, dose-ranging study to compare the risk/benefit ratio of large- and small-dose aprotinin with placebo after major orthopedic surgery. Fifty-eight patients were randomized into three groups: Large-Dose Aprotinin (4 M kallikrein inactivator unit [KIU] bolus before surgery followed by a continuous infusion of 1 M KIU/h until the end of surgery), Small-Dose Aprotinin (2 M KIU bolus plus 0.5 M KIU/h), and Placebo. Bleeding was measured and calculated. Bilateral ascending venography was systematically performed on the third postoperative day. Measured and calculated blood loss decreased in the Large-Dose Aprotinin group (calculated bleeding, whole blood, hematocrit 30%, median [range], 2,023 mL [633-4,113] as compared with placebo, 3,577 mL [1,670-21,758 mL]). The total number of homologous and autologous units was also significantly decreased in the Large-Dose Aprotinin group (2 U [0-5 U] as compared with placebo, 4 U [0-42 U]). No increase in deep vein thrombosis or pulmonary embolism was observed in the aprotinin groups. Large-dose aprotinin was safe and effective in dramatically reducing the measured and calculated bleeding and the amount of transfused red blood cell units after major orthopedic surgery. IMPLICATIONS: Large doses of aprotinin decrease blood loss and transfusion amount in major orthopedic surgery.

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