Planned Semi-Elective Lung Tx Study

NCT04601818 | Completed

• 1 other identifier: IRB202001646
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures; Lung Transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)

  72 hours post op

Secondary Outcomes (1)

• 1-year survival

  procedure up to 1 year post op

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Retrospective arm

NO INTERVENTION

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.

Interventions

Experimental: Preserving of Donor Lungs PROCEDURE

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

Interventional arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary lung transplantation
• Informed consent provided

You may not qualify if:

• Re-transplantation
• Multi-organ transplantation
• Age \>70y
• Concerns with organ preservation technique

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UFHealth Shands

Gainesville, Florida, 32601, United States

Location

Study Officials

• Mindaugas Rackauskas, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: October 26, 2020
• Study Start: November 30, 2020
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: March 30, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)