Phase 4
Completed N=30
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Extracorporeal Membrane Oxygenation Complication · Pediatric ALL · Anticoagulants
Source: ClinicalTrials.gov NCT03318393 ↗
Enrolled (actual)
30
Serious AEs
46.7%
Results posted
Jan 2023
Primary outcomePrimary: Percentage of Time Spent at Goal Anticoagulation — 0.63; 0.49 percentage of time
◆ Published Evidence
Emerging
12citations · ~12 / year
Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.
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.
Linked Publications
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Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Spent at Goal Anticoagulation |
0.63; 0.49 | — |
| SECONDARY Number of Participants With One or More Major Bleeding Events |
7; 7 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03318393) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.