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


CONCLUSIONS
Large doses of aprotinin decrease blood loss and transfusion amount in major orthopedic surgery.
Samama
Charles Marc
CM
Département d'Anesthésie-Réanimation, Centre Hospitalo-Universitaire (CHU) Avicenne, Bobigny, France. cmsamama@invivo.edu
Langeron
Olivier
O
Rosencher
Nadia
N
Capdevila
Xavier
X
Rouche
Patricia
P
Pegoix
Michel
M
Bernière
Josée
J
Coriat
Pierre
P
D000328:Adult; D000768:Anesthesia, General; D007611:Aprotinin / Q000009:adverse effects / Q000627:therapeutic use*; D001772:Blood Cell Count; D016063:Blood Loss, Surgical / Q000517:prevention & control; D001803:Blood Transfusion; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006400:Hematocrit; D006470:Hemorrhage / Q000097:blood / Q000517:prevention & control; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000009:adverse effects*; D010976:Platelet Count; D011183:Postoperative Complications / Q000517:prevention & control*
D006490:Hemostatics; D007611:Aprotinin