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

Phase 4

• Conditions: Extracorporeal Membrane Oxygenation Complication; Anticoagulants
• Interventions: Drug: Bivalirudin; Drug: Unfractionated heparin

• Registration Number: NCT03965208
• Lead Sponsor: Legacy Health System

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.

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05-23
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-24
• Last Update Submitted: 2019-05-24
• Study First Posted: 2019-05-28
• Last Update Posted: 2019-05-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Age ≥18 years
2. Require ECMO and systemic anticoagulation as determined by the primary treating physician
3. Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds

Exclusion Criteria

1. Prior inclusion in this study
2. Patients with known or suspected heparin induced thrombocytopenia
3. Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
4. Allergy to heparin or related products or bivalirudin
5. Known anti-thrombin deficiency
6. Selection of a non-standard aPTT target range

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalirudin	Bivalirudin	Patients randomized to this group will receive anticoagulation with bivalirudin
Unfractionated heparin	Unfractionated heparin	Patients randomized to this group will receive anticoagulation with unfractionated heparin

Primary Outcome Measures

Name	Time	Method
Percentage of time in the target anticoagulation range	From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks	activated partial thromboplastin time

Secondary Outcome Measures

Name	Time	Method
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
Major bleeding events	From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

Trial Locations

Locations (1)

Legacy Health System; 🇺🇸 Portland, Oregon, United States