Multicenter trial of desirudin for the prophylaxis of thrombosis: an alternative to heparin-based anticoagulation (DESIR-ABLE)
Clinical trial published in Clin Appl Thromb Hemost (2012)
Abstract
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 (<100 x 10(9)/mL, n = 50), severe obesity (body mass index >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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
In the DESIR-ABLE multicenter single-arm study, 516 perioperative or medically ill patients received desirudin 15 mg every 12 hours for VTE prophylaxis; no major bleeds and no VTE-related deaths occurred.
Why This Matters for Hirudotherapy
This single-arm, open-label multicenter study evaluated the safety of desirudin — a subcutaneous direct thrombin inhibitor derived from hirudin, the anticoagulant originating in medicinal-leech saliva — in 516 hospitalized perioperative and medically ill patients requiring VTE prophylaxis, with major bleeding as the primary endpoint. For hirudotherapy, the work is relevant because it extends clinical safety data for a hirudin-based therapeutic into a broader, higher-risk inpatient population that included patients with renal impairment, severe obesity, and thrombocytopenia, reinforcing the translational value of the leech secretome beyond topical wound use. The investigators reported no major bleeds and no VTE-related deaths. An honest caveat: because DESIR-ABLE was uncontrolled and non-randomized, it cannot establish comparative efficacy or superiority over heparin-based prophylaxis, and the authors themselves note that confirmatory trials in specific surgical or medically ill populations are still needed.
Citation
Reference (Vancouver style)
Bergese SD, Minkowitz HS, Arpino PA, Sane DC, Levy JH. Multicenter trial of desirudin for the prophylaxis of thrombosis: an alternative to heparin-based anticoagulation (DESIR-ABLE). Clin Appl Thromb Hemost. 2013;19(4):418-423. doi:10.1177/1076029612452779. PMID: 22802554
Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.
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