An interventional study of Experimental: Preserving of Donor Lungs in To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures and Lung Transplant, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6pm and 4am, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6am start or later with the lungs being preserved at 10C cold static preservation upon organ arrival to our hospital using a specific refrigerator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12h.
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Donor Inclusion: Age\<70
Exclusion Criteria:
Donor exclusion criteria:
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.
Procedure: Experimental: Preserving of Donor Lungs
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.
lung transplants that have a proposed after hours start time will be delayed until 6am and the donor lungs will be preserved for no more than 12 hours at 10 degrees celsius cold static
Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)
Time frame: 72 hours post op
1-year survival
Time frame: procedure up to 1 year post op
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Florida