Status:
COMPLETED
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Extracorporeal Membrane Oxygenation Complication
Pediatric ALL
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief 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 unf...
Detailed Description
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 unf...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03318393
Start Date
March 25 2018
End Date
October 8 2021
Last Update
January 31 2023
Active Locations (1)
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1
Children's Medical Center
Dallas, Texas, United States, 75235