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

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.

Conditions

Lung Transplant

Study Overview

Study Details

Study overview

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.

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

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

Condition
Lung Transplant
Intervention / Treatment

-

Contacts and Locations

Louisville

University Of Louisville, Louisville, Kentucky, United States, 40202

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Temple University Hospital, Philadelphia, Pennsylvania, United States, 19140

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Mauricio Villavicencio, MD, MBA, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-09