Pilot Study of Anticoagulation-Free Veno-Venous ECMO in Adults with Acute Respiratory Failure
Led by Damian Ratano · Updated on 2026-01-16
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of an anticoagulation-free strategy for adults with acute respiratory distress syndrome ARDS who require veno-venous extracorporeal membrane oxygenation VV-ECMO. This pilot study addresses the current practice of therapeutic anticoagulation, which varies worldwide but typically uses unfractionated heparin, and explores the possibility that anticoagulation may not be necessary during VV-ECMO due to lower risk of systemic embolization compared to other ECMO types.
The study randomly assigns participants to one of two groups one group will receive no unfractionated heparin during ECMO but will get standard venous thromboembolism prevention with subcutaneous heparin or enoxaparin, while the other group will receive the standard anticoagulation with intravenous unfractionated heparin during ECMO. The trial compares these approaches over an average ECMO duration of 14 days.
Participants will be monitored for complications related to ECMO, including thrombotic and hemorrhagic events, throughout the treatment period. Various assessments and safety evaluations will be conducted during ECMO support, with a focus on measuring thrombotic complications as the primary outcome. The total participation involves the ECMO treatment duration and related clinical follow-up for safety and feasibility assessments.
CONDITIONS
Brief Title
Anticoagulation-free VV ECMO for Acute Respiratory Failure
Research Team
D
Damian Ratano, MD
E
Eddy Fan, MD, PhD
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Contraindication to anticoagulation with UFH such as known heparin-induced thrombocytopenia or active hemorrhage
Any surgery that prevents the use of anticoagulation
Indication for therapeutic anticoagulation due to pulmonary embolism, deep vein thrombosis, or chronic anticoagulation therapy before ECMO
Low-flow VV-ECMO less than 2 liters per minute (ECCO2R)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 14 days (duration of ECMO support)
Participants receive veno-venous ECMO with either prophylactic subcutaneous heparin or standard therapeutic intravenous heparin as anticoagulation during ECMO support.
Daily visits during ECMO support
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficiency in extracorporeal membrane oxygenation-cellular deposits on polymethylpentene membranes increase resistance to blood flow and reduce gas exchange capacity.
Non-heparinized ECMO serves a rescue method in a multitrauma patient combining pulmonary contusion and nonoperative internal bleeding: a case report and literature review.
Technical complications during veno-venous extracorporeal membrane oxygenation and their relevance predicting a system-exchange--retrospective analysis of 265 cases.