American Society of Hirudotherapy

Bivalirudin versus unfractionated heparin for prevention of hemofilter occlusion during continuous renal replacement therapy

Research article published in Pharmacotherapy (2010)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Randomized controlled trialDrug DevelopmentKiser TH et al. · Pharmacotherapy, 2010

Abstract

STUDY OBJECTIVE: To evaluate the safety and efficacy of bivalirudin compared with heparin for preventing hemofilter occlusion during continuous venovenous hemofiltration (CVVH). DESIGN: Prospective, randomized, double-blind study. SETTING: University-affiliated hospital. PATIENTS: Ten critically ill adults (median age 58 yrs, 70% male) with acute renal failure who, without anticoagulation, experienced hemofilter survival time of 24 hours or less during CVVH. INTERVENTION: Patients were randomized to receive bivalirudin 2 mg/hour (five patients) or heparin 400 units/hour (five patients) administered prefilter into the extracorporeal circuit. MEASUREMENTS AND MAIN RESULTS: Patients had a median Acute Physiology and Chronic Health Evaluation (APACHE) II score of 24, Sequential Organ Failure Assessment (SOFA) score of 11, and reduced antithrombin activity (75.5 units/dl). Baseline characteristics were not significantly different between groups. Study drug was administered in 40 hemofilters (18 from bivalirudin-treated patients, 22 from heparin-treated patients). The primary efficacy outcome was hemofilter survival time, defined as the interval of time between commencement of CVVH with a new extracorporeal circuit (hemofilter) and hemofilter failure. Compared with no anticoagulation, the addition of bivalirudin or heparin significantly improved hemofilter survival time (mean ± SD 10 ± 5 hrs with no anticoagulation vs 22 ± 18 hrs with anticoagulation, p=0.0005). Hemofilter survival time was significantly increased in patients receiving bivalirudin versus those receiving heparin (29.6 ± 20.7 vs 16.5 ± 13.6 hrs, p=0.045). Independent predictors of hemofilter survival were use of bivalirudin therapy and increased antithrombin III activity. No patients randomized to bivalirudin experienced any bleeding or thrombosis events; one patient who received heparin developed alveolar hemorrhage, and one developed a lower extremity deep vein thrombosis. CONCLUSION: Compared with heparin, bivalirudin was more efficacious in prolonging hemofilter survival time and was well tolerated. Additional studies of bivalirudin for prevention of hemofilter occlusion during continuous renal replacement therapy are warranted.

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

Publication typeComparative StudyJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov't
Indexed MeSH termsAcute Kidney InjuryAnticoagulantsAntithrombinsCritical IllnessDouble-Blind MethodFemaleHemofiltrationHeparinHirudinsHumansMaleMiddle Aged

Summary

Bivalirudin versus unfractionated heparin for prevention of hemofilter occlusion during continuous renal replacement therapy.

Why This Matters for Hirudotherapy

This prospective, randomized, double-blind study in ten critically ill adults with acute renal failure compared bivalirudin (2 mg/hr) versus heparin (400 units/hr) for preventing hemofilter occlusion during continuous venovenous hemofiltration. Bivalirudin significantly prolonged hemofilter survival time compared with heparin (29.6 vs. 16.5 hrs), and no bivalirudin-treated patient experienced bleeding or thrombosis, whereas one heparin patient developed alveolar hemorrhage and another developed DVT. The ASH relevance lies in bivalirudin being a hirudin-based direct thrombin inhibitor, demonstrating efficacy of this leech-inspired drug class in extracorporeal circuit anticoagulation. However, the sample size was very small (n=10), this involved a pharmaceutical agent rather than leech therapy or crude leech extract, and the findings require confirmation in larger studies.

Citation

Bivalirudin versus unfractionated heparin for prevention of hemofilter occlusion during continuous renal replacement therapy

Kiser TH et al. · Pharmacotherapy, 2010

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

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