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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
titrated continuous infusion
titrated continuous infusion
Legacy Health System
Portland, Oregon, United States
RECRUITINGPercentage of time in the target anticoagulation range
activated partial thromboplastin time
Time frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks
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
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