Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

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