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Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation — BIV-ECMO2  

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03965208
Study type Interventional
Source Legacy Health System
Contact R Brigg Turner, PharmD
Phone 503-352-7288
Email brigg.turner@pacificu.edu
Status Recruiting
Phase Phase 4
Start date May 23, 2019
Completion date December 31, 2020
View Details
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