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Cold Lung Preservation for Lung Transplant

N/A
Recruiting
Led By Marcelo Cypel, MD MSc
Research Sponsored by University Health Network, Toronto
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 1 year post-transplant
Awards & highlights

Study Summary

This trial aims to assess the safety and efficacy of a new method of donor lung preservation that involves prolonged preservation at 10°C in the X°Port Lung Transport Device, which could reduce primary graft dysfunction and improve post-transplant outcomes.

Who is the study for?
This trial is for lung transplant recipients whose donor lungs are suitable for immediate transplantation without needing extra assessment. Donors can be after brain or cardiac death, but the lungs must not require ex vivo lung perfusion evaluation.Check my eligibility
What is being tested?
The study compares two methods of preserving donor lungs before a transplant: one uses a new device to keep the lungs at about 10°C, and the other uses standard ice cooler preservation at approximately 4°C. The goal is to see if the new method reduces severe lung injury post-transplant.See study design
What are the potential side effects?
Since this trial focuses on organ preservation techniques rather than medications, there aren't typical side effects like with drugs. However, risks may include potential complications related to how well the preserved lungs function after being transplanted.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant 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 Primary Graft Dysfunction (PGD) Grade 3 as per International Society for Heart and Lung Transplantation (ISHLT)
Secondary outcome measures
Forced expiratory volume - one second (FEV1 in L)
Incidence of Primary Graft Dysfunction Grade 2-3 as per International Society for Heart and Lung Transplantation
Occurrence of acute rejection
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 10°C lung preservationExperimental Treatment1 Intervention
Group II: Standard lung preservationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER
704 Previous Clinical Trials
6,143,063 Total Patients Enrolled
University of California, San FranciscoOTHER
2,507 Previous Clinical Trials
15,238,275 Total Patients Enrolled
Mayo ClinicOTHER
3,216 Previous Clinical Trials
3,767,188 Total Patients Enrolled

Media Library

Lung transplantation after 10°C donor lung preservation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05898776 — N/A
Organ Preservation Research Study Groups: Standard lung preservation, 10°C lung preservation
Organ Preservation Clinical Trial 2023: Lung transplantation after 10°C donor lung preservation Highlights & Side Effects. Trial Name: NCT05898776 — N/A
Lung transplantation after 10°C donor lung preservation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05898776 — N/A

Frequently Asked Questions

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

Does this experiment accept participants over the age of 45?

"This clinical trial is seeking participants who are between 18 and 80 years old."

Answered by AI

Is there a way I can join this research program?

"Eligibility for this medical trial necessitates organ preservation and an age range between 18 years old to 80. The investigators are hoping to recruit a total of 300 participants."

Answered by AI

Is there still availability for participants in this research project?

"The study in question, which was first shared on June 15th 2023, is currently not recruiting any more patients. According to clinicaltrials.gov however, there are 16 other trials actively searching for participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
10°C vs 4°C Lung Preservation RCT
2023. "10°C vs 4°C Lung Preservation RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05898776.
~180 spots leftby Jul 2025
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