Anticoagulants, Extracorporeal Membrane Oxygenation Complication
Conditions
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.
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
DRUGBivalirudin
titrated continuous infusion
DRUGUnfractionated heparin
titrated continuous infusion
Sponsors
Pacific University
Legacy Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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
| 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 |
Countries
United States
Contacts
Primary ContactR Brigg Turner, PharmD
Backup ContactJoseph Deng, MD
Outcome results
None listed