DRUG
Bivalirudin
titrated continuous infusion
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation
Status
Unknown
Phase
Phase 4
Enrollment
34
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Unfractionated heparin
titrated continuous infusion
Timeline
From registration to results.
First posted
May 28, 2019
Study start
May 23, 2019
Primary completion
Dec 31, 2020
Study completion
Dec 31, 2020
Results posted
Not reported
Registry updated
May 28, 2019
Outcomes
What the study measures.
Primary outcomes
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 outcomes
Major bleeding events
Time frame · From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Major clinical thrombotic events
Time frame · From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Duration of oxygenator use
Time frame · From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Legacy Health System
Portland, Oregon, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Bivalirudin.
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Related PeptideStat pages
Put the record in context.
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