Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Phase 4

Completed

• Conditions: Anticoagulants; Pediatric ALL; Extracorporeal Membrane Oxygenation Complication
• Interventions: Drug: Bivalirudin; Drug: Unfractionated heparin

• Registration Number: NCT03318393
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Study Start: 2018-03-25
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-08
• Results First Submitted: 2022-10-11
• Status Verified: 2022-12
• Results First Submitted QC: 2023-01-28
• Last Update Submitted: 2023-01-28
• Results First Posted: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalirudin group	Bivalirudin	Patients randomized to this arm will receive anticoagulation with bivalirudin
Unfractionated heparin group	Unfractionated heparin	Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.

Primary Outcome Measures

Name	Time	Method
Percentage of Time Spent at Goal Anticoagulation	through study completion, an average of 1-2 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With One or More Major Bleeding Events	through study completion, an average of 1-2 weeks	Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States