drugset / Trial / NCT06442267

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

NCT06442267

Phase 4 Recruiting 90 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2024-07-30
Primary completion
2027-01-30
Completion
2027-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Argatroban Small molecule 0.1 ug/kg Intravenous
Subject Argatroban Small molecule 1 ug/kg Intravenous
Subject Enoxaparin sodium Other / unclassified 0.5 mg/kg Subcutaneous
Comparator Heparin Other / unclassified 7.5 iu/kg Intravenous
Comparator Heparin Other / unclassified 20 iu/kg Intravenous