DRUG
Bivalirudin
Continuous infusion
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Status
Completed
Phase
Phase 4
Enrollment
30
Locations
1
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Unfractionated heparin
Continuous infusion
Timeline
From registration to results.
First posted
Oct 23, 2017
Study start
Mar 25, 2018
Primary completion
Oct 8, 2021
Study completion
Oct 8, 2021
Results posted
Jan 31, 2023
Registry updated
Jan 31, 2023
Outcomes
What the study measures.
Primary outcomes
Percentage of Time Spent at Goal Anticoagulation
Time frame · through study completion, an average of 1-2 weeks
Secondary outcomes
Number of Participants With One or More Major Bleeding Events
Time frame · 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
Eligibility
Who can take part.
- Minimum age
- 1 Day
- Maximum age
- 18 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Children's Medical Center
Dallas, Texas, United States
Publications
Results and literature.
Related trials
More studies on Bivalirudin.
NCT IDStudyPhase / statusEnrollmentUpdated
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
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Recruiting
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2026-07
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Xiaotong Hou · Extracorporeal Membrane Oxygenation Complication
Not applicable
Recruiting
154
2026-04
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
Peking University First Hospital · Coronary Microvascular Dysfunction
Phase 4
Recruiting
70
2025-08
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