Planned Semi-Elective Lung Tx Study

Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-Of-Concept Study

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant; To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures
• Intervention / Treatment: Procedure: Experimental: Preserving of Donor Lungs

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32601
      • UFHealth Shands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; 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; 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
No Intervention: Retrospective arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours (expected rate less than 20%)	72 hours post op

Secondary Outcome Measures

Outcome Measure	Time Frame
1-year survival	procedure up to 1 year post op

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Mindaugas Rackauskas, MD, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB202001646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No