American Society of Hirudotherapy

Evaluation of dose requirements for prolonged bivalirudin administration in patients with renal insufficiency and suspected heparin-induced thrombocytopenia

Cohort study published in Journal of Thrombosis and Thrombolysis (2012)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Observational studyClinical TrialsDrug DevelopmentWisler JW et al. · Journal of Thrombosis and Thrombolysis, 2012

Abstract

Bivalirudin, a direct thrombin inhibitor, is indicated for patients with suspected heparin-induced thrombocytopenia (HIT) with anticipated percutaneous coronary intervention (PCI). Data is limited on dose selection among patients with renal insufficiency, particularly with prolonged infusion durations. The study cohort comprised 73 patients with renal dysfunction who received bivalirudin for suspected HIT with or without acute coronary syndrome. We reviewed individual pharmacy and medical records for laboratory and bivalirudin dosing information, medical comorbidities, and adverse clinical outcomes during administration. When estimated glomerular filtration rate (eGFR) was calculated by the Cockcroft-Gault (CG; ml/min) formula, the average bivalirudin dose (mg/kg/h) achieving a therapeutic activated partial thromboplastin time (aPTT) was 0.07 ± 0.04, 0.15 ± 0.08, and 0.16 ± 0.07 for patients with eGFR between 15-30, 31-60, and >60, respectively. When eGFR was calculated by the modification of diet in renal disease (MDRD; ml/min/1.73 m(2)) formula, the average bivalirudin dose achieving a therapeutic aPTT was 0.07 ± 0.04, 0.12 ± 0.07, and 0.20 ± 0.07 for patients with eGFR between 15-30, 31-60, >60, respectively. The difference between the dose achieving a therapeutic aPTT for patients with eGFR >60 when calculated by MDRD versus CG was completely abolished when obese patients were excluded from the CG cohort. The results of our series of patients with renal dysfunction receiving prolonged duration of bivalirudin in the setting of acute coronary syndrome (ACS) suggests that dose adjustment is safe and should be considered for patients with moderate to severe renal impairment (eGFR < 60 ml/min/1.73 m(2)).

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

Publication typeComparative StudyJournal Article
Indexed MeSH termsAgedAged, 80 and overCohort StudiesDose-Response Relationship, DrugDrug EvaluationFemaleHeparinHirudinsHumansMaleMiddle AgedPeptide Fragments

Summary

Cohort of 73 patients with renal dysfunction receiving prolonged bivalirudin for suspected HIT; the dose achieving therapeutic aPTT was 0.07–0.20 mg/kg/h depending on eGFR, supporting dose adjustment in moderate-to-severe renal impairment.

Why This Matters for Hirudotherapy

This retrospective review of 73 patients with renal dysfunction examined bivalirudin dosing requirements during prolonged infusion for suspected heparin-induced thrombocytopenia, finding that therapeutic aPTT was achieved at lower average doses in patients with reduced eGFR and concluding that dose adjustment appears safe for moderate-to-severe renal impairment (eGFR <60). Bivalirudin is a synthetic direct thrombin inhibitor structurally modeled on hirudin, the anticoagulant secreted by medicinal leeches, so this work is relevant to ASH's domain because it informs how a leech-secretome-derived anticoagulant strategy can be titrated in vulnerable patient populations. An honest caveat is that this is a single-center retrospective series, not a randomized trial, and its findings are specific to the HIT/acute coronary syndrome setting rather than to hirudotherapy itself.

Citation

Evaluation of dose requirements for prolonged bivalirudin administration in patients with renal insufficiency and suspected heparin-induced thrombocytopenia.

Wisler JW et al. · Journal of Thrombosis and Thrombolysis, 2012

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

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