RECRUITING

A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

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

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

Official Title

Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial

Quick Facts

Study Start:2022-09-17
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05547698

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. * Bilateral Lung Transplantation (LTx) recipients.
  2. * Mean pulmonary artery pressure \< or = 35 mmHg.
  3. * Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.
  1. * Single lung transplant
  2. * Multiorgan transplant.
  3. * Donor after cardiac death (DCD).
  4. * Re-transplant.
  5. * Intention to use prophylactic post-operative ECMO.
  6. * Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.
  7. * Previous pleurodesis.
  8. * Preoperative ECMO and/or mechanical ventilation.

Contacts and Locations

Study Contact

Mauricio Villavicencio, MD, MBA
CONTACT
507-2557068
villavicencio.mauricio@mayo.edu
Jackie Reiter
CONTACT
507-538-2224
reiter.jacqulyn@mayo.edu

Principal Investigator

Mauricio Villavicencio, MD, MBA
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

University Of Louisville
Louisville, Kentucky, 40202
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Mauricio Villavicencio, MD, MBA, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2022-09-17
Study Completion Date2025-09

Study Record Updates

Study Start Date2022-09-17
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Bilateral

Additional Relevant MeSH Terms

  • Lung Transplant