Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.

ABSTRACT:

Objectives

To test feasibility of a randomized controlled trial (RCT) with an endpoint of time at goal anticoagulation in children on extracorporeal membrane oxygenation (ECMO) randomized to receive bivalirudin vs. unfractionated heparin.

Design

Open-label pilot RCT (NCT03318393) carried out 2018-2021.

Setting

Single-center quaternary U.S. pediatric hospital.

Patients

Children 0 days to younger than 18 years old supported with ECMO in the PICU or cardiovascular ICU.

Interventions

Randomization to bivalirudin vs. unfractionated heparin while on ECMO.

Measurements and main results

Sixteen patients were randomized to bivalirudin, and 14 patients were randomized to heparin. There was no difference in the primary outcome, time spent at goal anticoagula

SUBMITTER: McMichael A 

PROVIDER: S-EPMC12159964 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature