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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna

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

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators