CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Bivalirudin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03318393
NCT03318393Phase 4Completed
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Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation

University of Texas Southwestern Medical Center·interventional·Posted Oct 23, 2017·Updated Jan 31, 2023

In Brief

A Phase 4 clinical trial evaluating Bivalirudin and Unfractionated heparin for Extracorporeal Membrane Oxygenation Complication and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtracorporeal Membrane Oxygenation Complication, Pediatric ALL, Anticoagulants
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 23, 2017
Enrollment StartMar 25, 2018
Primary CompletionOct 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.7 years ago

Interventions

Bivalirudindrug

Continuous infusion

Unfractionated heparindrug

Continuous infusion