Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06442267

Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban, and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support

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

90

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different anticoagulation methods for patients requiring extracorporeal membrane oxygenation (ECMO) support due to respiratory or circulatory failure. This phase IV, randomized controlled pilot study compares the standard treatment using unfractionated heparin with two alternatives: argatroban and enoxaparin. The goal is to determine if enoxaparin or argatroban are not worse than unfractionated heparin in preventing blood clots during ECMO therapy. Participants will be randomly assigned to one of three groups receiving anticoagulation during ECMO: subcutaneous enoxaparin given twice daily at 0.5 mg/kg, continuous intravenous argatroban infusion adjusted to target specific thrombin time levels, or continuous intravenous unfractionated heparin infusion adjusted to target anti-FXa levels. Anticoagulation treatment continues for the duration of ECMO support, which typically averages about 14 days. During the study, researchers will monitor participants for the occurrence of blood clots and bleeding events throughout their ECMO run. Assessments include regular measurements of clotting parameters to adjust medication doses appropriately. The primary outcome is the incidence of thromboembolic events during ECMO therapy. Participation involves close medical observation until ECMO support ends, with safety and treatment effectiveness closely tracked by the medical team.

CONDITIONS

Brief 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
  • Age 18 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Duration of ECMO therapy, averaging 14 days

Participants receive anticoagulation therapy using one of three drugs: subcutaneous Enoxaparin, intravenous Argatroban, or intravenous unfractionated heparin during ECMO support.

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

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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