Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Study Overview
=================
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.

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

Conditions
-----------------
Extracorporeal Membrane Oxygenation Complication, Pediatric ALL, Anticoagulants

Intervention / Treatment
-----------------
* Drug: Bivalirudin
* Drug: Unfractionated heparin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unfractionated heparin group<br>Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. | Drug: Unfractionated heparin<br>* Continuous infusion<br>|
| Experimental: Bivalirudin group<br>Patients randomized to this arm will receive anticoagulation with bivalirudin | Drug: Bivalirudin<br>* Continuous infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time Spent at Goal Anticoagulation |  | through study completion, an average of 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |