Anticoagulation-free VV ECMO for Acute Respiratory Failure: A Pilot Safety and Feasibility Randomized Clinical Trial
Who is this study for? Patients with Acute Respiratory Distress Syndrome
What treatments are being studied? Subcutaneous Heparin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patient with ARDS on VV-ECMO
Locations
Other Locations
Canada
Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Damian Ratano, MD
damian.ratano@chuv.ch
+1 416-340-3601
Backup
Eddy Fan, MD, PhD
eddy.fan@uhn.ca
+1 416-340-3601
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 40
Treatments
Experimental: No anticoagulation
Participants in this arm will not receive unfractionated heparin during the course of ECMO. They will receive standard venous thromboembolism prophylaxis with subcutaneous enoxaparin or unfractionated heparin
No_intervention: Anticoagulation, ECMO standard of care
Participants in this arm will receive the standard of care anticoagulation with unfractionated heparin during the course of ECMO.
Related Therapeutic Areas
Sponsors
Collaborators: The Physicians' Services Incorporated Foundation
Leads: Damian Ratano