Lung Transplant, To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures
Conditions
Brief summary
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.
Interventions
PROCEDUREExperimental: Preserving of Donor Lungs
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
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Primary lung transplantation * Informed consent provided Donor Inclusion: Age\<70
Exclusion criteria
* Re-transplantation * Multi-organ transplantation Donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%) | 72 hours post op |
Secondary
| Measure | Time frame |
|---|---|
| 1-year survival | procedure up to 1 year post op |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMindaugas Rackauskas, MD, PhD
University of Florida
Outcome results
None listed