Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation (BIV-ECMO2)

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

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.

Study Overview

• Status: Unknown
• Conditions: Extracorporeal Membrane Oxygenation Complication; Anticoagulants
• Intervention / Treatment: Drug: Unfractionated heparin; Drug: 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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97123
      • Recruiting
      • Legacy Health System
      • Contact: Joseph Deng, MD; Phone Number: 503-413-2000; Email: jdeng@lhs.org
      • Contact: Kyle Kojiro, PharmD; Phone Number: 503-413-2000; Email: kkojiro@lhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unfractionated heparin; Patients randomized to this group will receive anticoagulation with unfractionated heparin	Drug: Unfractionated heparin; titrated continuous infusion
Experimental: Bivalirudin; Patients randomized to this group will receive anticoagulation with bivalirudin	Drug: Bivalirudin; titrated continuous infusion; 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	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

Other Outcome Measures

Outcome Measure	Time Frame
Number of blood products received	From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
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

Collaborators and Investigators

• Sponsor: Legacy Health System
• Collaborators: Pacific University
• Investigators: Principal Investigator: R Brigg Turner, PharmD, Pacific University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin; Calcium heparin
• Other Study ID Numbers: 1665-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes