title: Randomized study of aprotinin effect on transfusions and blood loss in primary THA.
abstract: A projected increase in total hip arthroplasties, shortfalls in blood availability, and awareness of complications of transfusion make blood management in orthopaedic surgery important. In a multicenter, randomized, double-blind, placebo-controlled study, we hypothesized use of aprotinin would reduce blood transfusions (any and allogeneic) and blood loss in total hip arthroplasty. Using an intent-to-treat approach, we recruited 393 patients stratified by preoperative autologous blood donation or none and then randomized them to receive aprotinin (176 patients receiving a 10,000 kallikrein inhibitor units [KIU] test dose, 2 million KIU load, 0.5 million KIU per hour) or placebo (177 patients). We assessed patients at baseline; postoperative days 1, 2, 3, and 7 (or discharge); and 6 +/- 2 weeks. Primary efficacy was percentage of patients having blood transfusion through day 7 or discharge. We based safety on reported adverse events. Aprotinin reduced transfusions by 46% (30 of 176 versus 56 of 177 patients). Aprotinin reduced the total number of any blood units and the number of allogeneic blood units transfused relative to placebo (48 versus 109 units and 30 versus 72 units, respectively). Serious complications were similar in the two groups (placebo, 11%; aprotinin, 10%). Our data suggest full-dose aprotinin is safe and effective in decreasing blood transfusion in total hip arthroplasty.
authors.affiliation: Shiley Center for Orthopaedic Research & Education at Scripps Clinic, La Jolla, CA 92037, USA. colwell@scripps.edu
authors.forename: Clifford W
authors.initials: CW
authors.lastname: Colwell
authors.forename: Jacques E
authors.initials: JE
authors.lastname: Chelly
authors.forename: John M
authors.initials: JM
authors.lastname: Murkin
authors.forename: David
authors.initials: D
authors.lastname: Stevens
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: O'Keefe
authors.forename: Richard
authors.initials: R
authors.lastname: Hall
authors.forename: Javad
authors.initials: J
authors.lastname: Parvizi
mesh_terms: D000368:Aged; D007611:Aprotinin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D019644:Arthroplasty, Replacement, Hip / Q000191:economics; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion / Q000191:economics; D002170:Canada; D004311:Double-Blind Method; D005260:Female; D017048:Health Care Costs; D006490:Hemostatics / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D013997:Time Factors; D014481:United States
chemical_list: D006490:Hemostatics; D007611:Aprotinin