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Procedure

Lung Transplant Techniques for Lung Transplant

N/A
Recruiting
Led By Mauricio Villavicencio, MD, MBA
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48-72 hours and 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two techniques for performing a bilateral lung transplant: off-pump vs venoarterial ECMO. The goal is to determine which has lower rates of primary graft dysfunction.

Who is the study for?
This trial is for people who need both lungs replaced and can have surgery with or without a heart-lung machine (ECMO), as decided by their surgeon. They must have a certain level of blood pressure in the lungs to qualify. It's not for those needing only one lung, multiple organs, re-transplants, or who had major lung surgeries before.
What is being tested?
The study compares two ways to do lung transplants: 'off-pump' without using ECMO and using venoarterial ECMO during the procedure. The main focus is on which method leads to fewer complications with the new lungs starting to work ('primary graft dysfunction').
What are the potential side effects?
Potential side effects may include issues related to the surgical procedure such as bleeding, infection, or problems with how well the new lungs work. Using ECMO might also lead to blood clots or damage at the site where it's connected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during va ecmo run
This trial's timeline: 3 weeks for screening, Varies for treatment, and during va ecmo run for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mortality
Lung
Lung
Secondary study objectives
Chest tube output
Incidence of Primary Lung Graft Dysfunction (PGD) grade 3
Incidence of air emboli
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Off-Pump Bilateral Lung TransplantationActive Control1 Intervention
Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care
Group II: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung TransplantationActive Control1 Intervention
Subjects will receive VA ECMO technique for lung transplantation as part of standard of care

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,733 Total Patients Enrolled
6 Trials studying Lung Transplant
7,713 Patients Enrolled for Lung Transplant
Mauricio Villavicencio, MD, MBAPrincipal InvestigatorMayo Clinic

Media Library

Off-pump lung transplantation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05547698 — N/A
Lung Transplant Research Study Groups: Off-Pump Bilateral Lung Transplantation, Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation
Lung Transplant Clinical Trial 2023: Off-pump lung transplantation Highlights & Side Effects. Trial Name: NCT05547698 — N/A
Off-pump lung transplantation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547698 — N/A
~52 spots leftby Sep 2025
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