Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Require ECMO support or have started ECMO therapy within the last 12 hours
- Age 18 years or older
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
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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