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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965208
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
Pacific University
Information provided by (Responsible Party):
R. Brigg Turner, 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.

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Complication Anticoagulants Drug: Bivalirudin Drug: Unfractionated heparin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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 Name: Angiomax




Primary Outcome Measures :
  1. Percentage of time in the target anticoagulation range [ Time Frame: 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 [ Time Frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks ]
  2. Major clinical thrombotic events [ Time Frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks ]
  3. Duration of oxygenator use [ Time Frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks ]

Other Outcome Measures:
  1. Number of blood products received [ Time Frame: 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 [ Time Frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965208


Contacts
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Contact: R Brigg Turner, PharmD 503-352-7288 brigg.turner@pacificu.edu
Contact: Joseph Deng, MD 503-413-2000 jdeng@lhs.org

Locations
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United States, Oregon
Legacy Health System Recruiting
Portland, Oregon, United States, 97123
Contact: Joseph Deng, MD    503-413-2000    jdeng@lhs.org   
Contact: Kyle Kojiro, PharmD    503-413-2000    kkojiro@lhs.org   
Sponsors and Collaborators
Legacy Health System
Pacific University
Investigators
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Principal Investigator: R Brigg Turner, PharmD Pacific University
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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    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heparin
Calcium heparin
Bivalirudin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors