VV-ECMO without therapeutic blood thinners for severe respiratory failure
Official title: Anticoagulation-free VV ECMO for Acute Respiratory Failure: A Pilot Safety and Feasibility Randomized Clinical Trial
Run by University Health Network, Toronto · NCT04273607 · Data updated 2026-11-12
This pilot trial tries running veno-venous ECMO without therapeutic anticoagulants to see if it's safe for adults with ARDS.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | January 30, 2027 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT04273607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with ARDS on veno-venous ECMO who have no current indication for therapeutic anticoagulation and no contraindication to the protocol.
✕Probably not a fit
Patients who require therapeutic anticoagulation (for example for pulmonary embolism or DVT), have heparin-induced thrombocytopenia, active major bleeding, recent surgery precluding anticoagulation, low-flow ECCO2R, or who need veno-arterial support are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study enrolls adult patients with ARDS supported on veno-venous ECMO and implements an anticoagulation-free management strategy using heparin-coated circuits and close monitoring. Participants meeting protocol criteria will generally receive only subcutaneous prophylactic heparin rather than continuous therapeutic unfractionated heparin. Outcomes include circuit thrombosis, thromboembolic events, major bleeding, need for circuit exchanges, and feasibility measures such as protocol adherence. The goal is to determine whether withholding therapeutic anticoagulation is safe and practicable in this population.
Why it matters
Potential benefit: If successful, this approach could reduce bleeding complications and simplify ECMO management by avoiding full-dose anticoagulation.
How similar studies have gone: Small case series and observational reports suggest anticoagulation-free VV-ECMO can be feasible and safe in select patients, but randomized trials are lacking.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Toronto General Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Damian Ratano, MD — University Health Network, Toronto
- Study coordinator: Damian Ratano, MD
- Email: damian.ratano@chuv.ch
- Phone: +1 416-340-3601
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.