Comparing lung transplant outcomes with a new preservation method
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-Of-Concept Study
NA · University of Florida · NCT04601818
This study is testing a new way to preserve donor lungs before transplant to see if it helps patients getting their first lung transplant do better than with the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04601818 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the outcomes of lung transplantation using a novel preservation technique that allows for donor lungs to be preserved at a specific temperature for up to 12 hours before transplantation. When donor lungs become available during specific hours, the transplant procedure can be scheduled for a later time, potentially improving the viability of the organs. The study will compare the results of this approach with those of standard lung transplant procedures. Participants will include patients receiving their first lung transplant and suitable donors under the age of 70.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing their first lung transplantation who have provided informed consent.
Not a fit: Patients requiring re-transplantation or multi-organ transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance lung transplant outcomes and increase the availability of viable donor organs.
How similar studies have performed: While similar preservation techniques have been explored, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary lung transplantation * Informed consent provided Donor Inclusion: Age\<70 Exclusion Criteria: * Re-transplantation * Multi-organ transplantation Donor exclusion criteria: * Age \>70y * Concerns with organ preservation technique
Where this trial is running
Gainesville, Florida
- UFHealth Shands — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Mindaugas Rackauskas, MD, PhD — University of Florida
- Study coordinator: Jessica Cobb
- Email: Jessica.Cobb@surgery.ufl.edu
- Phone: 352-273-7837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures, Lung Transplant