Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

  • STATUS
    Recruiting
  • End date
    Jan 7, 2022
  • participants needed
    30
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 7 March 2021

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.

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.

Details
Condition childhood ALL, Anticoagulants, Extracorporeal Membrane Oxygenation Complication, Lymphocytic Leukemia, Acute, anticoagulant, blood thinner, agents, anticoagulant, anticoagulation agents, blood thinners, anticoagulant drugs
Treatment Bivalirudin, Unfractionated heparin
Clinical Study IdentifierNCT03318393
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on7 March 2021

Eligibility

Yes No Not Sure

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
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