Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Pediatric ALL Clinical Trial

Official title:

Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318393
• Other study ID #: 072017-045
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Anticoagulants
• Extracorporeal Membrane Oxygenation Complication
• Pediatric ALL

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