Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Completed · Phase 4

Conditions studied: Extracorporeal Membrane Oxygenation Complication, Pediatric ALL, Anticoagulants

In brief

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.

Key facts

Study ID

NCT03318393

Run by

University of Texas Southwestern Medical Center

People needed

30

Starts

2018-03-25

Expected to finish

2021-10-08

Last updated by the study team

2023-01-31

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 1 day to less than 18 years
• Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit
• receiving venovenous or venoarterial ECMO

You may not qualify if…

• Patients with known or suspected heparin induced thrombocytopenia prior to consent
• Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values
• Patients with plan to decannulate from ECMO within 48 hours
• Known or suspected pregnant women
• Previous enrollment in this study
• Primary language spoken that is not English or Spanish

Where it is running

• Children's Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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