Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Extracorporeal Membrane Oxygenation Complication; Anticoagulants; Pediatric ALL

Treatments: Drug: Unfractionated heparin; Drug: Bivalirudin

Study type: Interventional

Funder types: Other

Identifiers

NCT03318393

072017-045

Details and patient eligibility

About

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 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.

Enrollment: 30 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Unfractionated heparin group

Active Comparator group

Description:

Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.

Treatment:

Drug: Unfractionated heparin

Bivalirudin group

Experimental group

Description:

Patients randomized to this arm will receive anticoagulation with bivalirudin

Treatment:

Drug: Bivalirudin