NCT06442267

Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Respiratory Insufficiency
• Circulatory Failure
• Thromboembolism
• Bleeding

Interventions

Type	Name	Description
DRUG	Enoxaparin Injectable Solution	Subcutaneous Enoxaparin will be dosed at 0.5 mg/kg twice daily
DRUG	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.
DRUG	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.

Timeline

• Start date: 2024-07-30
• Primary completion: 2027-01-30
• Completion: 2027-07-30
• First posted: 2024-06-04
• Last updated: 2024-10-29

Locations

1 site across 1 country: Austria