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Published on: January 17, 2025
Evaluation of a Bivalirudin Dosing and Monitoring Protocol in Pediatric Extracorporeal Membrane Oxygenation
Layne M Smith1, Francis L Casey Iii2, Dhaval Chauhan3
1Department of Pharmacy (LMS), West Virginia University Medicine Children's, Morgantown, WV.
Insights
Bivalirudin dosing for pediatric extracorporeal membrane oxygenation (ECMO) varies significantly by patient age. Optimal anticoagulation requires considering factors like age, renal, and hepatic function for effective bivalirudin therapy.
Area of Science:
- Pediatric critical care medicine
- Pharmacology and therapeutics
- Cardiopulmonary support technologies
Background:
- Bivalirudin is a direct thrombin inhibitor utilized off-label for anticoagulation in extracorporeal membrane oxygenation (ECMO).
- Limited data exists on pediatric bivalirudin dosing during ECMO, a critical gap given the heterogeneity of this patient population.
Purpose of the Study:
- To characterize the use and optimal dosing of bivalirudin in pediatric patients undergoing ECMO at a single center.
Main Methods:
- Retrospective chart review of pediatric patients receiving bivalirudin for ECMO between January 2021 and June 2023.
- Primary outcome: bivalirudin dose to achieve goal activated partial thromboplastin time (aPTT).
- Secondary outcomes included time in therapeutic range, bleeding incidence, and blood product usage.
Main Results:
- Fourteen pediatric patients (6 neonates, 5 children, 3 adolescents) were analyzed.
- Median ECMO duration was 6 days.
- Median bivalirudin doses to achieve initial aPTT goals differed by age group: 0.1 mg/kg/hr (neonates), 0.2 mg/kg/hr (children), and 0.05 mg/kg/hr (adolescents).
Conclusions:
- Pediatric bivalirudin dosing for ECMO is influenced by patient-specific factors.
- Age, ECMO indication, renal, and hepatic function are crucial considerations for initiating bivalirudin therapy.
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.
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