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Anticoagulation-free ECMO for Respiratory Insufficiency (A-FREE ECMO Trial)
Phase 2 & 3
Recruiting
Led By Damian Ratano, MD
Research Sponsored by Damian Ratano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patient with ARDS on VV-ECMO
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through ecmo completion, an average of 14 days
Awards & highlights
A-FREE ECMO Trial Summary
This trial is testing whether it is safe to use ECMO without anticoagulation for ARDS patients.
Who is the study for?
This trial is for adults with Acute Respiratory Distress Syndrome (ARDS) who are on VV-ECMO treatment. It's not open to those with a history of heparin-induced thrombocytopenia, active bleeding, recent surgeries that don't allow anticoagulation, or if they need anticoagulants for other conditions like blood clots.Check my eligibility
What is being tested?
The study is testing the safety and feasibility of using VV-ECMO without the standard blood-thinning medication (therapeutic anticoagulation). Participants will receive subcutaneous Heparin instead to see if it can prevent clotting complications safely.See study design
What are the potential side effects?
Potential side effects may include risks associated with not using therapeutic anticoagulants such as clot formation in the ECMO circuit or patient's body. Subcutaneous Heparin could cause bruising at injection sites, bleeding issues, or allergic reactions.
A-FREE ECMO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with ARDS and am on a VV-ECMO machine.
A-FREE ECMO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through ecmo completion, an average of 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through ecmo completion, an average of 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extracorporeal Membrane Oxygenation
Secondary outcome measures
Hemorrhagic complications
Other outcome measures
Amount of clot and fibrin visualized in the pre- and post-membrane side
Coagulation parameters on ECMO
Increase in d-dimer levels
+1 moreA-FREE ECMO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: No anticoagulationExperimental Treatment1 Intervention
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
Group II: Anticoagulation, ECMO standard of careActive Control1 Intervention
Participants in this arm will receive the standard of care anticoagulation with unfractionated heparin during the course of ECMO.
Find a Location
Who is running the clinical trial?
PSI Foundation, Toronto, OntarioUNKNOWN
Damian RatanoLead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
Damian Ratano, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take heparin due to allergies, bleeding, or recent surgery.I am an adult with ARDS and am on a VV-ECMO machine.You are receiving a low amount of blood flow support through a special machine called VV-ECMO.I am on blood thinners for a clot in my lung or leg.
Research Study Groups:
This trial has the following groups:- Group 1: Anticoagulation, ECMO standard of care
- Group 2: No anticoagulation
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research the first of its kind in this area?
"63 active trials for Subcutaneous Heparin are underway in 362 cities and 27 countries. The first study was conducted in 2006 by Ash Access Technology. That initial Phase 3 clinical trial included 415 patients and completed drug approval stage successfully. Since then, 327 more trials have been completed."
Answered by AI
Are there any current openings for participants in this clinical research?
"The listing on clinicaltrials.gov verifies that this clinical trial is presently looking for enrollees. This study was originally published on September 1st, 2022 and was last updated on August 19th, 2022. The research is admitting 40 participants at 1 location."
Answered by AI
What are some common conditions that Subcutaneous Heparin is used to address?
"Subcutaneous Heparin, which is injected just under the skin, can be used to prevent peripheral arterial embolism and is also helpful for treating other conditions like general surgery, sprains, and when using medical devices."
Answered by AI
To your knowledge, how many times has Subcutaneous Heparin been studied?
"63 Subcutaneous Heparin studies are currently being conducted with 22 of them in Phase 3. The global distribution of these medical trials is significant, with 652 total locations, and a notable concentration in Nieuwegein and Utrecht."
Answered by AI
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