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Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
Sponsor: Medical University of Vienna
Summary
A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy
Official title: A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-07-30
Completion Date
2027-07-30
Last Updated
2024-10-29
Healthy Volunteers
No
Interventions
Enoxaparin Injectable Solution
Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
Argatroban, 1 Mg/mL Intravenous Solution
Intravenous Argatroban will be administered as a continuous infusion of 0.1-1 µg/kg/min with a target modified thrombin time measured using Hemoclot of 0,40 - 0,60 µg/mL.
Unfractionated heparin
Unfractionated heparin will be administered as a continuous infusion of 7.5-20 units/kg/h with a target Anti FXa calibrated for UFH of 0.3-0.5 u/mL.
Locations (1)
Medical University of Vienna
Vienna, Vienna, Austria