Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation
NCT ID: NCT03965208
Last Updated: 2019-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
34 participants
INTERVENTIONAL
2019-05-23
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unfractionated heparin
Patients randomized to this group will receive anticoagulation with unfractionated heparin
Unfractionated heparin
titrated continuous infusion
Bivalirudin
Patients randomized to this group will receive anticoagulation with bivalirudin
Bivalirudin
titrated continuous infusion
Interventions
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Bivalirudin
titrated continuous infusion
Unfractionated heparin
titrated continuous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Pacific University
OTHER
Legacy Health System
OTHER
Responsible Party
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R. Brigg Turner
Principal investigator
Principal Investigators
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R Brigg Turner, PharmD
Role: PRINCIPAL_INVESTIGATOR
Pacific University
Locations
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Legacy Health System
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1665-2019
Identifier Type: -
Identifier Source: org_study_id
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