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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
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 moreTrial 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?
Puerta de Hierro University HospitalOTHER
71 Previous Clinical Trials
26,203 Total Patients Enrolled
Centre Hospitalier Universitaire VaudoisOTHER
256 Previous Clinical Trials
14,036,624 Total Patients Enrolled
Vanderbilt UniversityOTHER
706 Previous Clinical Trials
6,143,203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a double lung transplant.My organ donation will be after brain or heart stops.I am interested in treatments that save my organs.I have received transplants for more than one organ.I have had a single lung transplant.I am between 18 and 80 years old.I require an evaluation of my lung's viability.The donor lungs I'm receiving are ready for transplant without needing further assessment.I have had a lung transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Standard lung preservation
- Group 2: 10°C lung preservation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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