About this trial
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
Eligibility criteria
Qualifiers
either
require ECMO support or
have been started on ECMO therapy within the last 12 hours
Disqualifiers
Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances
Patients who are pregnant
Patients suffering from a clinically relevant pre-existing coagulopathy
Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation
Trial design
Treatments tested in this trial
- Enoxaparin Injectable Solution
- Argatroban, 1 Mg/mL Intravenous Solution
- Unfractionated heparin