American Society of Hirudotherapy

Bivalirudin use in an infant with persistent clotting on unfractionated heparin

Case report published in Journal of Pediatric Pharmacology and Therapeutics (2011)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Case reportClinical TrialsDrug DevelopmentMalloy KM et al. · Journal of Pediatric Pharmacology and Therapeutics, 2011

Abstract

Bivalirudin is a direct thrombin inhibitor approved for use in adult patients with heparin-induced thrombocytopenia (HIT) undergoing percutaneous coronary intervention. Recently, its use in the pediatric population has increased due to its anti-thrombin-independent mechanism of action. As heparin products produce great inter- and intraindividual variability in pediatric patients, often due to decreased anti-thrombin concentrations in the first year of life, some practitioners have turned to direct thrombin inhibitors, such as bivalirudin, for more predictable pharmacokinetics and effects on bound and circulating thrombin. We report our experience using bivalirudin in a 2-month-old female with recurrent systemic thrombi despite continuous unfractionated heparin infusion. Due to the patient's inability to maintain therapeutic activated partial thromboplastin time (aPTT) values during heparin infusion, bivalirudin was initiated at 0.1 mg/kg/h and increased due to subtherapeutic aPTTs to a maximum of 0.58 mg/kg/h. Therapeutic aPTTs were achieved at the increased dose; however, the patient's worsening renal impairment with resultant drug accumulation and overwhelming sepsis on day 5 of therapy led to discontinuation of the infusion and the initiation of comfort measures.

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

Publication typeCase ReportsJournal Article

Summary

Two-month-old female with recurrent systemic thrombi unresponsive to unfractionated heparin; bivalirudin was titrated from 0.1 to 0.58 mg/kg/h and achieved therapeutic aPTTs before being discontinued due to renal impairment and sepsis.

Why This Matters for Hirudotherapy

This case report describes bivalirudin use in a 2-month-old female with recurrent systemic thrombi despite continuous unfractionated heparin infusion. It reports that therapeutic aPTTs were achieved after dose escalation, but worsening renal impairment with drug accumulation and overwhelming sepsis led to discontinuation and initiation of comfort measures on day 5. The abstract does not mention leeches, hirudin, leech saliva, or hirudotherapy, so it provides no defensible connection to ASH's domain or the leech secretome. Its limitations are those of a case report: a single critically ill infant, no leech therapy, and no inference about hirudotherapy outcomes.

Citation

Bivalirudin use in an infant with persistent clotting on unfractionated heparin.

Malloy KM et al. · Journal of Pediatric Pharmacology and Therapeutics, 2011

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.