American Society of Hirudotherapy

Evaluation of Intraoperative Bivalirudin Anticoagulation in Neonates and Infants Undergoing Arterial Switch Operation on Integrated ECMO-CPB Circuit: A Prospective Study

Research article published in Journal of cardiothoracic and vascular anesthesia (2025)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Research reportDrug DevelopmentBadge HM et al. · Journal of cardiothoracic and vascular anesthesia, 2025

Abstract

OBJECTIVES: To ascertain the dosage of bivalirudin in neonates and infants undergoing arterial switch operation on integrated extracorporeal membrane oxygenation-cardiopulmonary bypass (CPB) circuit. DESIGN: Pilot study. SETTING: A tertiary care hospital. PARTICIPANTS: Ten neonates and infants with transposition of great arteries undergoing an arterial switch operation INTERVENTIONS: The patients received a bivalirudin bolus dose of 1 mg/kg followed by a maintenance dose of 2.5 mg/kg/h. The infusion dose was adjusted to maintain an activated clotting time (ACT) >480 s. MEASUREMENTS AND MAIN RESULTS: The mean age and weight were 92 ± 67 days and 4.1 ± 1.45 kg, respectively. There were more male children than female (8:2). The mean baseline ACT score was 207.6 ± 52.4 s. The bolus dose required was 1 mg/kg, and two children required an additional bolus dose of 0.5 mg/kg. The mean ACT of the priming solution was 999 s, and the mean ACT following the bolus dose was 575.9 ± 101 s. The maintenance dose required was 2.1 ± 0.3 mg/kg/h. The mean ACT on CPB after 30 min, 60 min, and 90 min was 956.2 ± 62.8 s, 936.8 ± 137 s, and 829.6 ± 232.5 s, respectively. There was no incidence of clot formation in the circuit or thromboembolic complications. CONCLUSIONS: Bivalirudin can be effectively used for anticoagulation during CPB in neonates and infants with transposition of great arteries, at a bolus dose of 1 mg/kg and a maintenance dose of 2.1 ± 0.3 mg/kg/h, utilizing the integrated extracorporeal membrane oxygenation-CPB circuit.

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

Publication typeJournal Article
Indexed MeSH termsHumansHirudinsMaleFemaleExtracorporeal Membrane OxygenationPeptide FragmentsInfant, NewbornProspective StudiesRecombinant ProteinsInfantPilot ProjectsCardiopulmonary Bypass

Summary

Evaluation of Intraoperative Bivalirudin Anticoagulation in Neonates and Infants Undergoing Arterial Switch Operation on Integrated ECMO-CPB Circuit: A Prospective Study.

Why This Matters for Hirudotherapy

This pilot study evaluated intraoperative bivalirudin anticoagulation in 10 neonates and infants undergoing arterial switch operation for transposition of great arteries using an integrated ECMO-CPB circuit. The study found that a bolus dose of 1 mg/kg followed by a maintenance dose of 2.1 ± 0.3 mg/kg/h maintained ACT above 480 seconds, with no clot formation in the circuit or thromboembolic complications. The abstract does not mention hirudin, leeches, or any leech-derived product, so no defensible connection to ASH's hirudotherapy domain or the leech secretome can be drawn from this source. As a small pilot study, the findings are exploratory and the authors do not claim definitive efficacy.

Citation

Evaluation of Intraoperative Bivalirudin Anticoagulation in Neonates and Infants Undergoing Arterial Switch Operation on Integrated ECMO-CPB Circuit: A Prospective Study

Badge HM et al. · Journal of cardiothoracic and vascular anesthesia, 2025

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

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