American Society of Hirudotherapy

A Comparative Analysis of Bivalirudin and Heparin for Extracorporeal Membrane Oxygenation in a Pediatric Cardiothoracic Intensive Care Unit

Retrospective study published in ASAIO J (2025)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Research reportDrug DevelopmentClinical TrialsDaniels Z et al. · ASAIO journal, 2025

Abstract

Unfractionated heparin has long been the conventional anticoagulant for pediatric mechanical circulatory support (MCS). As bivalirudin has gained traction in ventricular assist devices (VAD) management, its role in extracorporeal membrane oxygenation (ECMO) is less well defined. We conducted a retrospective, single-center study investigating the safety and outcomes of bivalirudin, a direct thrombin inhibitor, compared to heparin in a pediatric cardiothoracic intensive care unit (ICU). Outcomes included thrombotic and bleeding events, neurologic complications, survival to decannulation/transplant, and discharge. There were 122 patients for a total of 130 ECMO runs. Bivalirudin was used in 30% of ECMO runs, and bivalirudin demonstrated a 33% risk reduction in major bleeding (95% confidence interval: [-49.9, -16.0], p < 0.01) with fewer circuit component changes per 10 ECMO days (0.64 [0.4-0.7] vs . 2.6 [1.9-5.0], p < 0.01). Extracorporeal membrane oxygenation patients on bivalirudin had greater odds of survival to decannulation (odds ratio [OR]: 3.7 [1.4, 11.5], p = 0.01) and discharge (OR: 3.1 [1.4, 7.2], p < 0.01). The use of bivalirudin for ECMO in the pediatric cardiothoracic ICU population appears safe with fewer major bleeding and thrombotic complications and may be associated with improved survival compared to heparin.

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

Publication typeJournal Article

Summary

Bivalirudin (30% of 130 ECMO runs) showed 33% risk reduction in major bleeding, fewer circuit interventions and 3.7x odds of decannulation survival versus heparin in pediatric cardiothoracic ICU.

Why This Matters for Hirudotherapy

This retrospective single-center study of 122 pediatric ECMO patients (130 runs) compared the direct thrombin inhibitor bivalirudin with heparin and reported a 33% relative risk reduction in major bleeding, fewer circuit component changes, and higher odds of survival to decannulation and discharge for the bivalirudin group. The relevance to hirudotherapy is indirect but instructive: bivalirudin is a synthetic peptide modeled on hirudin, the natural anticoagulant from the medicinal leech, so this work reflects the broader clinical momentum behind leech-secretome-derived direct thrombin inhibition as an anticoagulant strategy. Caveat: the study evaluates a synthetic hirudin-inspired drug, not leech therapy itself, and as a retrospective single-center comparison it cannot establish causation; it is supportive context for the secretome drug-discovery narrative, not evidence for clinical leeching.

Citation

A Comparative Analysis of Bivalirudin and Heparin for Extracorporeal Membrane Oxygenation in a Pediatric Cardiothoracic Intensive Care Unit.

Daniels Z et al. · ASAIO journal, 2025

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

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