Anticoagulation-free VV ECMO for Acute Respiratory Failure
Recruiting
Phase 2
Phase 3
Interventional Study
Extracorporeal Membrane Oxygenation Complication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Damian Ratano · Other
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About This Trial
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…
Trial Locations
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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 embol…
Contacts