A trial to assess the benefits of an ECMO-free protocol for patients on venovenous ECMO.
ECMO-Free Trial: A Multicenter Randomized Controlled Trial
This study tests if a new daily check-in process can help patients on venovenous ECMO get off the machine safely and sooner than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT05486559 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a protocolized daily assessment for readiness to liberate patients from venovenous extracorporeal membrane oxygenation (VV-ECMO) compared to usual care. The study will involve patients receiving VV-ECMO in participating adult hospitals, where they will be assessed daily to determine the safest and earliest time for decannulation. The goal is to improve clinical outcomes, reduce costs, and optimize resource allocation by standardizing the weaning process. The trial seeks to provide robust data on the impact of this protocolized approach on the duration of ECMO support and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults currently receiving VV-ECMO in participating hospitals.
Not a fit: Patients who are pregnant, under 18, or receiving ECMO as a bridge to transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced healthcare costs for patients on VV-ECMO.
How similar studies have performed: Previous studies have indicated that protocolized assessments for liberation from organ support are superior to clinician judgment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient receiving VV-ECMO * Patient is located in a participating unit of an adult hospital Exclusion Criteria: * Patient is pregnant * Patient is a prisoner * Patient is \< 18 years old * Participant is receiving ECMO as bridge to transplant * Participant is receiving a hybrid configuration that includes an arterial cannula * Patient has received VV-ECMO for \> 48 hours
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- Hennepin County Medical Center — Minneapolis, Minnesota, United States (Recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Whitney D Gannon, MSN, MS
- Email: whitney.gannon@vumc.org
- Phone: 6109095789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.