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

Sponsor
Legacy Health System (Other)
Overall Status
Unknown status
CT.gov ID
NCT03965208
Collaborator
Pacific University (Other)
34
Enrollment
1
Location
2
Arms
19.3
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
May 23, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Major bleeding events [From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks]

    2. Major clinical thrombotic events [From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks]

    3. Duration of oxygenator use [From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks]

    Other Outcome Measures

    1. Number of blood products received [From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Legacy Health System Portland Oregon United States 97123

    Sponsors and Collaborators

    • Legacy Health System
    • Pacific University

    Investigators

    • Principal Investigator: R Brigg Turner, PharmD, Pacific University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    R. Brigg Turner, Principal investigator, Legacy Health System
    ClinicalTrials.gov Identifier:
    NCT03965208
    Other Study ID Numbers:
    • 1665-2019
    First Posted:
    May 28, 2019
    Last Update Posted:
    May 28, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Heparin
    Calcium heparin
    Bivalirudin

    Study Results

    No Results Posted as of May 28, 2019