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

RecruitingPhase 4Ages 18 Years - anyAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * either * require ECMO support or * have been started on ECMO therapy within the last 12 hours Exclusion Criteria: * 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 * Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism) * Patients whose total duration of ECMO support lasts less than 24 hours * Patients with start of ECMO support during CPR (eCPR) * Patients with passive decarboxylation, without an active pumping system * Patients, who have been weaned off ECMO support within the last 30 days * Patients with central ECMO cannulation and/or after cardiopulmonary bypass
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What it tests

  • Enoxaparin Injectable Solution
  • Argatroban, 1 Mg/mL Intravenous Solution
  • Unfractionated heparin
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Where

1 site
Medical University of Vienna
Vienna, Austria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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