Off-Pump Bilateral Lung Transplantation for Lung Transplant

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Lung Transplant
Off-pump lung transplantation - Procedure
Eligibility
18+
All Sexes
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Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: During VA ECMO run

48-72 hours
Primary Lung Graft Dysfunction (PGD) grade 3
Day 90
Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality
90 days
Mortality
Day 90
Incidence of bronchial dehiscence
Incidence of need for dialysis
Incidence of pneumonia
Incidence of stroke
Incidence of tracheostomy
Incidence of transplant rejection
Length of mechanical ventilation
Length of stay
Hour 24
Incidence of Primary Lung Graft Dysfunction (PGD) grade 3
During VA ECMO run
Incidence of air emboli
First 24 hours
Chest tube output
First 48 hours
Incidence of re-exploration for bleeding
Hour 24
Red blood cell transfusions

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Off-Pump Bilateral Lung Transplantation
1 of 2
Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Trans...
1 of 2
Active Control

228 Total Participants · 2 Treatment Groups

Primary Treatment: Off-Pump Bilateral Lung Transplantation · No Placebo Group · N/A

Off-Pump Bilateral Lung Transplantation
Procedure
ActiveComparator Group · 1 Intervention: Off-pump lung transplantation · Intervention Types: Procedure
Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation
Procedure
ActiveComparator Group · 1 Intervention: Venoarterial ECMO lung transplantation · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during va ecmo run
Closest Location: Massachusetts General Hospital · Boston, MA
Photo of Massachusetts General Hospital 1Photo of Massachusetts General Hospital 2Photo of Massachusetts General Hospital 3
1993First Recorded Clinical Trial
2 TrialsResearching Lung Transplant
2430 CompletedClinical Trials

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,685,933 Total Patients Enrolled
3 Trials studying Lung Transplant
361 Patients Enrolled for Lung Transplant
Mauricio Villavicencio, MD, MBAPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.