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CARDIOVASCULAR ANESTHESIA

Aprotinin Versus Placebo in Major Orthopedic Surgery: A Randomized, Double-Blinded, Dose-Ranging Study

Charles Marc Samama, MD PhD^*, Olivier Langeron, MD, Nadia Rosencher, MD, Xavier Capdevila, MD PhD, Patricia Rouche, MD^||, Michel Pegoix, MD^¶, Josée Bernière, MD^#, and Pierre Coriat, MD for the Hémorragies et Aprotinine en Chirurgie Orthopédique Lourde Study Group

*Département d’Anesthésie-Réanimation, Centre Hospitalo-Universitaire (CHU) Avicenne, Bobigny; Département d’Anesthésie-Réanimation, CHU Pitié-Salpêtrière, Paris; Département d’Anesthésie-Réanimation, CHU Cochin, Paris; Département d’Anesthésie-Réanimation A, Hôpital Lapeyronie, CHU de Montpellier, Montpellier; ||Département d’Anesthésie-Réanimation, Hôpital Saint Joseph, Paris; ¶Département d’Anesthésie-Réanimation, CHU de Caen–Côte de Nacre, Caen; and #Département d’Anesthésie-Réanimation, CHU Trousseau, Paris, France

Address correspondence and reprint requests to Charles Marc Samama, Département d’Anesthésie-Réanimation, Hôpital Avicenne 125, Route de Stalingrad, 93009 Bobigny Cedex, France. Address e-mail to cmsamama{at}invivo.edu

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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