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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Legacy Health System
• Collaborator: Pacific University
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

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