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

Last updated: October 26, 2024
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

4

Condition

Thromboembolism

Low Blood Pressure (Hypotension)

Lung Injury

Treatment

Unfractionated heparin

Argatroban, 1 Mg/mL Intravenous Solution

Enoxaparin Injectable Solution

Clinical Study ID

NCT06442267
1644/2022
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • either

  • require ECMO support or

  • have been started on ECMO therapy within the last 12 hours

Exclusion

Exclusion Criteria:

  • Patients exhibiting contraindications to anticoagulation in general or any of thethree investigated substances

  • Patients who are pregnant

  • Patients suffering from a clinically relevant pre-existing coagulopathy

  • Patients, for whom screening, randomization and implementation of study protocolcannot be initiated within 12 hours after cannulation

  • Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMOimplantation, 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

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Unfractionated heparin
Phase: 4
Study Start date:
July 30, 2024
Estimated Completion Date:
July 30, 2027

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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