NCT06442267 Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
| NCT ID | NCT06442267 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Vienna |
| Condition | Respiratory Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2024-07-30 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Johannes Gratz, PD, MD, PhD
PRINCIPAL INVESTIGATOR
Medical Univeristy of Vienna
Frequently Asked Questions
Who can join the NCT06442267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06442267 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06442267 currently recruiting?
Yes, NCT06442267 is actively recruiting participants. Contact the research team at vincenz.scharner@meduniwien.ac.at for enrollment information.
Where is the NCT06442267 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06442267 clinical trial?
NCT06442267 is sponsored by Medical University of Vienna. The principal investigator is Johannes Gratz, PD, MD, PhD at Medical Univeristy of Vienna. The trial plans to enroll 90 participants.