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NCT03318393 · ClinicalTrials.gov registry record · Phase 4
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
A Phase 4 study of Pediatric ALL and Extracorporeal Membrane Oxygenation Complication, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03318393 is a Phase 4 study of Pediatric ALL and Extracorporeal Membrane Oxygenation Complication that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 1,647-participant average among 21 other Pediatric ALL trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03318393, a Phase 4 study of Pediatric ALL and Extracorporeal Membrane Oxygenation Complication, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Bivalirudin
- DRUG Unfractionated heparin
Study Locations (1)
Texas
- Children's Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-03-25 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03318393
The ClinicalTrials.gov registry entry for NCT03318393 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,647-participant average among 21 other Pediatric ALL trials with a reported enrollment target (98% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pediatric ALL appearing as the primary indexed condition, and to 2 interventions - of which Bivalirudin is the first listed.
NCT03318393 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03318393 about?
NCT03318393 is a clinical study titled "Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO". 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 ar...
What is the current status of trial NCT03318393?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2018-03-25. Estimated completion is 2021-10-08.
What conditions does trial NCT03318393 study?
This clinical trial studies the following conditions: Pediatric ALL, Extracorporeal Membrane Oxygenation Complication, Anticoagulants.
What interventions are being tested in trial NCT03318393?
The interventions under investigation include: Bivalirudin (DRUG), Unfractionated heparin (DRUG).
Who is sponsoring clinical trial NCT03318393?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03318393 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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