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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

Study 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.Check my eligibility

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').See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ during va ecmo run

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mortality

Lung

Secondary outcome measures

Chest tube output

Incidence of Primary Lung Graft Dysfunction (PGD) grade 3

Incidence of air emboli

+10 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,767,026 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results is the research team hoping to see from this trial?

"This clinical trial aims to measure Primary Lung Graft Dysfunction (PGD) grade 3 over a period of 48-72 hours and 90 days. In addition, the incidence of tracheostomy, transplant rejection, and stroke will be evaluated in terms of subject numbers that require these treatments."

Answered by AI

Are there any vacancies for enrollees in this trial?

"Evidently, this medical trial is still recruiting patients as evidenced by its listing on clinicaltrials.gov. The original posting date was September 17th 2022 and the latest update occurred two days later on the 19th."

Answered by AI

What is the capacity of this research project in terms of participant numbers?

"Affirmative. The clinicaltrials.gov website notes that this research endeavour, which was initially posted on September 17th 2022, is presently searching for volunteers to participate. As many as 228 individuals must be enrolled from 6 distinct sites."

Answered by AI

Is this experiment being conducted in multiple locations within Canada?

"This medical research is recruiting patients from Mayo Clinic Florida in Jacksonville, FL, Mayo Clinic Rochester in Rochester, MN and Temple University Hospital in Philadelphia pa as well as 6 additional medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mauricio A. Villavicencio Theoduloz 2022. "A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547698.

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