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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03318393
Other study ID # 072017-045
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 25, 2018
Est. completion date October 8, 2021

Study information

Verified date December 2022
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 8, 2021
Est. primary completion date October 8, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Day to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bivalirudin
Continuous infusion
Unfractionated heparin
Continuous infusion

Locations

Country Name City State
United States Children's Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Blood Products Transfused Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate through study completion, an average of 1-2 weeks
Primary Percentage of Time Spent at Goal Anticoagulation through study completion, an average of 1-2 weeks
Secondary Number of Participants With One or More Major Bleeding Events Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding through study completion, an average of 1-2 weeks
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