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

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— BIV-ECMO2  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965208
• Other study ID #: 1665-2019
• Status: Recruiting
• Phase: Phase 4
• Start date: May 23, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: Legacy Health System
• Contact: R Brigg Turner, PharmD
• Phone: 503-352-7288
• Email: brigg.turner[@]pacificu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants
• Extracorporeal Membrane Oxygenation Complication

Intervention

Drug:
• Bivalirudin
titrated continuous infusion
• Unfractionated heparin
titrated continuous infusion

Locations

Country	Name	City	State
United States	Legacy Health System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Legacy Health System	Pacific University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of blood products received		From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Other	Percentage of patients that reach the target anticoagulation range within the first 24 hours		From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Primary	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	Major bleeding events		From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Secondary	Major clinical thrombotic events		From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Secondary	Duration of oxygenator use		From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks