What is this study studying for patients needing ECMO support?

This study is comparing three anticoagulation methods—unfractionated heparin, argatroban, and enoxaparin—to see if the newer options are not worse than the standard treatment in preventing blood clots during ECMO. Researchers want to find the safest and most effective way to manage blood thinning in patients on ECMO supported by the Medical University of Vienna.

Who may be eligible for this respiratory or circulatory failure clinical trial?

Adults 18 years and older who require ECMO support or started ECMO within the last 12 hours may be eligible. People who are pregnant, have bleeding disorders, or are already on anticoagulation treatment may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this ECMO anticoagulation clinical trial?

Study-related care, including anticoagulation drugs and all trial visits, is provided at no cost. However, personal travel or other expenses may not be covered and can vary by participant.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID06442267

Pilot Study Comparing Anticoagulation with Unfractionated Heparin, Argatroban, and Enoxaparin During Extracorporeal Membrane Oxygenation Support

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

Participants Needed

Research Sites

25 weeks

Total Duration

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 mgkg, 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

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

Research Team

Vincenz Scharner, MD

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