Comparing blood thinners for patients on ECMO support
A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support
This study is testing whether two different blood thinners, argatroban and enoxaparin, can work as well as the usual treatment, heparin, for patients on ECMO support.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06442267 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of three different anticoagulation strategies—unfractionated heparin, argatroban, and enoxaparin—during extracorporeal membrane oxygenation (ECMO) therapy. It is a randomized controlled trial designed to determine if enoxaparin or argatroban can provide similar outcomes to the standard treatment of unfractionated heparin in preventing thromboembolic events. The study will measure the incidence of these events in patients requiring ECMO support. Conducted at a single center, this phase IV study aims to improve anticoagulation management in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates are patients who require ECMO support or have started ECMO therapy within the last 12 hours.
Not a fit: Patients with contraindications to anticoagulation or those who have been weaned off ECMO support within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective anticoagulation strategies for patients on ECMO support.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown varying degrees of success with different anticoagulation strategies in critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * either * require ECMO support or * have been started on ECMO therapy within the last 12 hours Exclusion Criteria: * Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances * Patients who are pregnant * Patients suffering from a clinically relevant pre-existing coagulopathy * Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation * Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, 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
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Johannes Gratz, PD, MD, PhD — Medical Univeristy of Vienna
- Study coordinator: Vincenz Scharner, MD
- Email: vincenz.scharner@meduniwien.ac.at
- Phone: +43 1 40400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.