Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06442267

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

Led by Medical University of Vienna · Updated on 2024-10-29

90

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Require ECMO support or have started ECMO therapy within the last 12 hours
Not Eligible

You will not qualify if you...

  • Contraindications to anticoagulation or to any of the three study drugs
  • Pregnancy
  • Clinically relevant pre-existing coagulopathy
  • Inability to start study protocol within 12 hours after ECMO cannulation
  • Ongoing therapeutic systemic anticoagulation before ECMO or indication for it
  • Total ECMO support expected to last less than 24 hours
  • ECMO started during cardiopulmonary resuscitation (eCPR)
  • Passive decarboxylation without active pumping system
  • Weaned off ECMO support within the last 30 days
  • Central ECMO cannulation and/or after cardiopulmonary bypass

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

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Research Team

V

Vincenz Scharner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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