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Lung Preservation for Lung Transplant

N/A
Recruiting
Led By Tiago Machuca, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Donor Inclusion: Age<70
Primary lung transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure up to 1 year post op
Awards & highlights

Study Summary

This trialallows transplant procedures to start later when donor lungs are available in a certain time window and preserved with a specific fridge. Maximum time between donor and recipient is 12h.

Who is the study for?
This trial is for patients who need a lung transplant and have given informed consent. It's open to those receiving their first lung transplant from donors under 70 years old. However, it excludes anyone needing multiple organ transplants or re-transplantation, as well as cases where the donor is over 70 or there are concerns with how the lungs are preserved.Check my eligibility
What is being tested?
The study tests a method of preserving donor lungs when they're available overnight (between 6pm-4am). The procedure can be delayed until after 6am using cold static preservation at our hospital for up to 12 hours between removal from the donor and starting anesthesia on the recipient.See study design
What are the potential side effects?
Since this trial involves standard transplantation procedures but with a different timing and preservation technique, side effects may include typical post-transplant complications such as infection risk, rejection of the new organ, or issues related to delayed surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a donor under 70 years old.
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I have had a lung transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure up to 1 year post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure up to 1 year post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)
Secondary outcome measures
1-year survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional armExperimental Treatment1 Intervention
During our study period, transplants with a planned recipient anesthesia starting time between 10:00pm-6:00am will be allowed to move to a 6:00-8:00am start at the earliest. To be eligible, donor lungs cross clamp time have to occur between 6pm and 4am and lungs need to be suitable for transplantation without the need for ex vivo lung evaluation. Lungs meeting criteria for direct transplantation will be transported in the usual fashion in a cooler of ice at 4oC and upon arrival to Shands UF Health they will immediately be transferred to cold static preservation at 10oC within a specific refrigerator placed in the Shands UF Health OR. The maximum preservation time from donor cold flush (cross clamp) to recipient anesthesia start should be 12 hours and the recipient procedure should not start before 6am.
Group II: Retrospective armActive Control1 Intervention
Outcomes will be compared to conventional transplant patients matched by age, medical diagnosis, BMI, lung allocation score and donor type ( DCD vs. NDD) using a 1:2 matching.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,630 Total Patients Enrolled
Tiago Machuca, MD, PhDPrincipal InvestigatorUniversity of Florida
Mindaugas Rackauskas, MD, PhDPrincipal InvestigatorUniversity of Florida

Media Library

Preserving of Donor Lungs (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601818 — N/A
Lung Transplant Outcomes Clinical Trial 2023: Preserving of Donor Lungs Highlights & Side Effects. Trial Name: NCT04601818 — N/A
Lung Transplant Outcomes Research Study Groups: Interventional arm, Retrospective arm

Frequently Asked Questions

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

How many participants are included in the experiment?

"Affirmative. Clinicaltrials.gov data suggests that the trial is actively recruiting participants, with 75 persons being sought from a single medical centre since its debut on November 30th 2020 and latest update on October 18th 2022."

Answered by AI

To which demographic is admission to this medical trial open?

"For admission to this study, patients must have a record of previous lung transplants conducted through conventional methods and need to be between 18-70 years old. 75 participants will ultimately be accepted into the trial."

Answered by AI

Is this trial currently recruiting participants?

"Affirmative. According to clinicaltrials.gov, this investigation is actively recruiting participants; it was originally posted on November 30th 2020 and updated most recently on October 18th 2022. It requires 75 patients from a single site for enrolment."

Answered by AI

Are senior citizens being included in the survey?

"According to the requirements for this medical research, participants must be at least 18 years old but no older than 70."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Planned Semi-Elective Lung Tx Study
2020. "Planned Semi-Elective Lung Tx Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04601818.
~3 spots leftby Jul 2024
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