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Anticoagulation-free ECMO for Respiratory Insufficiency (A-FREE ECMO Trial)

Phase 2 & 3

Waitlist Available

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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through ecmo completion, an average of 14 days

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 20 Other Conditions

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with ARDS and am on a VV-ECMO machine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot take heparin due to allergies, bleeding, or recent surgery.

Select...

I am on blood thinners for a clot in my lung or leg.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through ecmo completion, an average of 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Extracorporeal Membrane Oxygenation

Secondary study objectives

Hemorrhagic complications

Other study objectives

Amount of clot and fibrin visualized in the pre- and post-membrane side

Coagulation parameters on ECMO

Increase in d-dimer levels

+1 more

Awards & Highlights

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.

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.

0 / 3Eligibility criteria met