American Society of Hirudotherapy

A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement

Randomized controlled trial published in N Engl J Med (1997)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialDrug DevelopmentClinical TrialsEriksson BI et al. · N Engl J Med, 1997

Abstract

BACKGROUND: Patients who undergo total hip replacement have a high risk of thromboembolic complications. Recombinant hirudin (desirudin), a specific inhibitor of thrombin, represents a new development in antithrombotic therapy. We compared the efficacy and safety of desirudin with those of a low-molecular-weight heparin (enoxaparin) for the prevention of thromboembolic complications in patients undergoing primary total hip replacement. METHODS: Both treatments, which were assigned in a randomized, double-blind manner, were started preoperatively: enoxaparin on the evening before surgery, and desirudin within 30 minutes before the start of surgery. The dose of desirudin was 15 mg subcutaneously twice daily, and the dose of enoxaparin was 40 mg subcutaneously once daily. The duration of treatment was 8 to 12 days. Deep-vein thrombosis was verified by bilateral venography performed at the end of the treatment period or earlier, if there were clinical signs of deep-vein thrombosis. RESULTS: At 31 centers in 10 European countries, 2079 eligible patients were randomly assigned to receive desirudin or enoxaparin. A total of 1587 patients were included in the primary analysis of efficacy. In the desirudin group, as compared with the enoxaparin group, there was a significantly lower rate of proximal deep-vein thrombosis (4.5 vs. 7.5 percent, P=0.01; relative reduction in risk, 40.3 percent) and a lower overall rate of deep-vein thrombosis (18.4 vs. 25.5 percent, P=0.001; relative reduction in risk, 28.0 percent). The safety profiles were similar in the two treatment groups. CONCLUSIONS: When administered 30 minutes before total hip replacement surgery, desirudin is more effective than enoxaparin in preventing deep-vein thrombosis.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeClinical TrialComparative StudyJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov't
Indexed MeSH termsAdolescentAdultAgedAged, 80 and overAnticoagulantsArthroplasty, Replacement, HipDouble-Blind MethodEnoxaparinFemaleHirudin TherapyHirudinsHumans

Summary

NEJM RCT in 2079 hip replacement patients comparing desirudin (15 mg sc bid) with enoxaparin (40 mg sc qd); desirudin reduced proximal DVT 4.5% vs 7.5% and overall DVT 18.4% vs 25.5%.

Why This Matters for Hirudotherapy

This multicenter, randomized, double-blind trial compared subcutaneous desirudin (recombinant hirudin, 15 mg twice daily starting within 30 minutes before surgery) with enoxaparin (40 mg once daily starting the evening before surgery) for prevention of thromboembolic complications in 2079 patients undergoing primary total hip replacement across 31 European centers, with bilateral venography confirmation. In the 1587-patient primary efficacy analysis, desirudin showed significantly lower proximal DVT (4.5% vs. 7.5%, p=0.01; 40.3% relative risk reduction) and overall DVT (18.4% vs. 25.5%, p=0.001; 28% relative risk reduction), with similar safety profiles between groups. This study is directly relevant to ASH's domain as it provides head-to-head clinical trial data for a recombinant leech-derived anticoagulant against a standard heparinoid. The caveat is that desirudin is a purified pharmaceutical compound, not whole leech therapy, and the abstract presents efficacy data from the primary analysis set rather than all randomized patients.

Citation

A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement.

Eriksson BI et al. · N Engl J Med, 1997

DOI

Added to ASH library: May 27, 2026 · Site last updated: June 18, 2026

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.