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Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

NCT03318393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-31

Study results available
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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

  • Extracorporeal Membrane Oxygenation Complication
  • Pediatric ALL
  • Anticoagulants

Interventions

DRUG

Bivalirudin

Continuous infusion

DRUG

Unfractionated heparin

Continuous infusion

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Ali McMichael, MD · UT Southwestern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-25
Primary Completion
2021-10-08
Completion
2021-10-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318393 on ClinicalTrials.gov