Evaluation of a Bivalirudin Dosing and Monitoring Protocol in Pediatric Extracorporeal Membrane Oxygenation
Retrospective protocol evaluation published in J Pediatr Pharmacol Ther (2025)
Abstract
OBJECTIVE: Bivalirudin is a direct thrombin inhibitor used off-label for systemic anticoagulation in extracorporeal membrane oxygenation (ECMO). There are limited data available in pediatric patients, specifically regarding optimal dosing in this heterogeneous population of patients. This study aimed to characterize bivalirudin use in pediatric patients on ECMO at a single center. METHODS: A retrospective chart review was conducted for consecutive patients undergoing ECMO at a quaternary center between January 2021 and June 2023 who received bivalirudin as the primary anticoagulation agent. The primary outcome was the dose of bivalirudin required to achieve activated partial thromboplastin time (aPTT) in the goal range. Additionally, time in therapeutic range, time to initial aPTT goal, dose adjustments required in patients receiving renal replacement therapy, amount of blood and blood products received, incidence of major bleeding, and complete ECMO circuit changes were evaluated. RESULTS: Fourteen patients, including 6 neonates, 5 children, and 3 adolescents, were included in the study. Eleven patients were initially placed on venoarterial ECMO, and 3 were initially placed on venovenous ECMO. The median ECMO duration was 6 days. The median dose of bivalirudin required to achieve the initial goal aPTT level varied between neonates, children, and adolescents (0.1 mg/kg/hr, 0.2 mg/kg/hr, 0.05 mg/kg/hr, respectively). CONCLUSIONS: Multiple patient factors including age, indication for ECMO, renal function, and hepatic function must be taken into consideration when determining a starting dose of bivalirudin for these pediatric patients.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Resumen
Bivalirudin doses for aPTT goal range varied between 14 ECMO patients (neonates 0.1, children 0.2, adolescents 0.05 mg/kg/hr); age, indication, renal/hepatic function influenced dosing.
Por qué esto importa para la hirudoterapia
Esta revisión retrospectiva de historias clínicas caracterizó el uso de bivalirudina —un inhibidor directo de la trombina empleado fuera de indicación aprobada para anticoagulación sistémica en ECMO— en 14 pacientes pediátricos en ECMO en un único centro cuaternario entre enero de 2021 y junio de 2023. El desenlace primario fue la dosis necesaria para alcanzar el tiempo de tromboplastina parcial activada objetivo, con medidas secundarias que incluyeron el tiempo dentro del rango terapéutico, eventos hemorrágicos y cambios de circuito. Los autores encontraron que las dosis medianas variaron sustancialmente según el grupo etario: 0,1 mg/kg/h para neonatos, 0,2 mg/kg/h para niños y 0,05 mg/kg/h para adolescentes, lo que enfatiza la necesidad de considerar factores específicos del paciente como la edad, la función renal y la función hepática al dosificar. El resumen no menciona hirudina, sanguijuelas ni ningún compuesto derivado de sanguijuelas, por lo que no existe una conexión defendible con la hirudoterapia. Se trata de una pequeña revisión retrospectiva unicéntrica sin grupo comparador y no involucra sanguijuelas ni hirudoterapia.
Citación
Evaluation of a Bivalirudin Dosing and Monitoring Protocol in Pediatric Extracorporeal Membrane Oxygenation.
Smith LM et al. · The journal of pediatric pharmacology and therapeutics, 2025
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Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: 18 de junio de 2026