NCT04273607 Anticoagulation-free VV ECMO for Acute Respiratory Failure
| NCT ID | NCT04273607 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Damian Ratano |
| Condition | Extracorporeal Membrane Oxygenation Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-12-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2022-09-01 with a primary completion date of 2026-12-31.
⚠ 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
Currently international experts recommend therapeutic anticoagulation for veno-venous extracorporeal membrane oxygenation (VV-ECMO). Reports and case series suggest that the absence of therapeutic anticoagulation is safe for VV-ECMO. No randomized control trials have assessed this. The aim of this pilot study is to assess safety and feasibility of an "anticoagulation-free strategy" for veno-venous ECMO (VV-ECMO) in Acute respiratory distress syndrome (ARDS).
Eligibility Criteria
Inclusion Criteria: * Adult patient with ARDS on VV-ECMO Exclusion Criteria: * Contraindication to anticoagulation with UFH (known heparin-induced thrombocytopenia, active hemorrhage, any surgery precluding the use of anticoagulation), * Indication for therapeutic anticoagulation (pulmonary embolism or deep vein thrombosis, chronic anticoagulation therapy before ECMO insertion) * Low-flow (\<2 liters/min) VV-ECMO (ECCO2R)
Contact & Investigator
Damian Ratano, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT04273607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extracorporeal Membrane Oxygenation Complication. 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 NCT04273607 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04273607 currently recruiting?
Yes, NCT04273607 is actively recruiting participants. Contact the research team at damian.ratano@chuv.ch for enrollment information.
Where is the NCT04273607 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04273607 clinical trial?
NCT04273607 is sponsored by Damian Ratano. The principal investigator is Damian Ratano, MD at University Health Network, Toronto. The trial plans to enroll 40 participants.