Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.

Detailed Description
-----------------
The investigators will randomly assign 34 adult patients requiring ECMO to receive bivalirudin or unfractionated heparin in a 1:1 fashion. There will be 17 patients in each group for a total of 34 patients. Unfractionated heparin binds to antithrombin thereby causing an anticoagulant effect while bivalirudin binds directly to thrombin. Use of unfractionated heparin in this population is problematic due to reliance on adequate levels of circulating antithrombin, complex pharmacokinetics, and variable clearance. Bivalirudin avoids many of these difficulties.

Official Title
-----------------
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2)

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Require ECMO and systemic anticoagulation as determined by the primary treating physician Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds Exclusion Criteria: Prior inclusion in this study Patients with known or suspected heparin induced thrombocytopenia Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment Allergy to heparin or related products or bivalirudin Known anti-thrombin deficiency Selection of a non-standard aPTT target range

Ages Eligible for Study
-----------------
Minimum 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<br>Patients randomized to this group will receive anticoagulation with unfractionated heparin | Drug: Unfractionated heparin<br>* titrated continuous infusion<br>|
| Experimental: Bivalirudin<br>Patients randomized to this group will receive anticoagulation with bivalirudin | Drug: Bivalirudin<br>* titrated continuous infusion<br>* Other names: Angiomax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in the target anticoagulation range | activated partial thromboplastin time | From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding events |  | From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks | 
| Major clinical thrombotic events |  | From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks | 
| Duration of oxygenator use |  | From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks |