drugset / Trial / NCT03318393

Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

NCT03318393

Phase 4 Completed 30 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.

Timeline

Start
2018-03-25
Primary completion
2021-10-08
Completion
2021-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide
Comparator Heparin Other / unclassified