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| Name | Class |
|---|---|
| Pacific University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfractionated heparin | Active Comparator | Patients randomized to this group will receive anticoagulation with unfractionated heparin |
|
| Bivalirudin | Experimental | Patients randomized to this group will receive anticoagulation with bivalirudin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | titrated continuous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in the target anticoagulation range | activated partial thromboplastin time | From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks |
| Measure | Description | 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R Brigg Turner, PharmD | Contact | 503-352-7288 | brigg.turner@pacificu.edu | |
| Joseph Deng, MD | Contact | 503-413-2000 | jdeng@lhs.org |
| Name | Affiliation | Role |
|---|---|---|
| R Brigg Turner, PharmD | Pacific University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Health System | Recruiting | Portland | Oregon | 97123 | United States |
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| Unfractionated heparin | Drug | titrated continuous infusion |
|
| Duration of oxygenator use | From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks |
| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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