ENROLLING_BY_INVITATION

The ECMO-Free Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Decannulation from venovenous extracorporeal membrane oxygenation (VV-ECMO) at the earliest and safest time would be expected to improve outcomes and reduce cost. Daily assessments for readiness to liberate from therapies have demonstrated success in other realms of critical care. A recent single-center study demonstrated that a protocolized daily assessment of readiness for liberation from VV-ECMO was feasible and did not raise any major safety concerns, but the effect of this protocolized daily assessment on clinical outcomes remains unclear. Further, the manner in which ECMO is provided, weaned, and discontinued varies significantly between centers, raising persistent concerns regarding widespread adoption of protocolized daily assessment of readiness for liberation from VV-ECMO. Data from large a randomized controlled trial is needed to compare the effects of a protocolized daily assessment of readiness for liberation from VV-ECMO versus usual care on duration of ECMO support and other clinical outcomes.

Official Title

ECMO-Free Trial: A Multicenter Randomized Controlled Trial

Quick Facts

Study Start:2022-09-07
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT05486559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient receiving VV-ECMO
  2. * Patient is located in a participating unit of an adult hospital
  1. * Patient is pregnant
  2. * Patient is a prisoner
  3. * Patient is \< 18 years old
  4. * Participant is receiving ECMO as bridge to transplant
  5. * Participant is receiving a hybrid configuration that includes an arterial cannula
  6. * Patient has received VV-ECMO for \> 48 hours

Contacts and Locations

Principal Investigator

Jonathan D Casey, MD, MSc
STUDY_DIRECTOR
Vanderbilt University Medical Center

Study Locations (Sites)

UC San Diego Health
San Diego, California, 92037
United States
Stanford University
Stanford, California, 94305
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Utah Health
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Jonathan D Casey, MD, MSc, STUDY_DIRECTOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-07
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2022-09-07
Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Extracorporeal Membrane Oxygenation Complication