Trials / Completed
CompletedNCT03318393
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Day – 18 Years
- Healthy volunteers
- Not accepted
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.
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 unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients. The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bivalirudin | Continuous infusion |
| DRUG | Unfractionated heparin | Continuous infusion |
Timeline
- Start date
- 2018-03-25
- Primary completion
- 2021-10-08
- Completion
- 2021-10-08
- First posted
- 2017-10-23
- Last updated
- 2023-01-31
- Results posted
- 2023-01-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03318393. Inclusion in this directory is not an endorsement.