Open AccessMulticenter Trial of Desirudin for the Prophylaxis of Thrombosis
Author(s) -
Sergio D. Bergese,
Harold S. Minkowitz,
Paul A. Arpino,
David C. Sane,
Jerrold H. Levy
Publication year - 2012
Publication title -
clinical and applied thrombosis/hemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.643
H-Index - 53
eISSN - 1938-2723
pISSN - 1076-0296
DOI - 10.1177/1076029612452779
Subject(s) - medicine , perioperative , thrombosis , population , surgery , clinical endpoint , venous thrombosis , clinical trial , creatinine , environmental health
Desirudin, a subcutaneously (SC) administered direct thrombin inhibitor, is indicated for prevention of venous thromboembolic events (VTEs) after total joint replacement surgery. DESIR-ABLE (multicenter trial of desirudin for the prophylaxis of thrombosis: an alternative to heparin-based anticoagulation) was a multicenter, open-label, single-arm study of hospitalized patients requiring VTE protection designed to extend the safety profile for desirudin to include a broad population of perioperative/critically ill patients. The primary end point was major bleeding. A total of 516 patients undergoing major surgery (378, 73%) or who were medically ill with prolonged immobility (138, 27%) were enrolled at 19 centers and received desirudin 15 mg Q12H. Many patients had high-risk features for bleeding and thrombosis such as thrombocytopenia ( 35, n = 145), and renal impairment (creatinine clearance <60 mL/min, n = 292). There were no major bleeds and no VTE-related deaths in this study. The DESIR-ABLE demonstrated the safety of desirudin in critically ill perioperative and medical patients. Trials in specific surgical or medically ill patients are needed to confirm these findings.