Planned Semi-Elective Lung Tx Study

NCT ID: NCT04601818

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2025-09-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental: Preserving of Donor Lungs

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Primary lung transplantation
• Informed consent provided

Donor Inclusion: Age<70

Exclusion Criteria

• Re-transplantation
• Multi-organ transplantation

• Age >70y
• Concerns with organ preservation technique

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mindaugas Rackauskas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UFHealth Shands

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Cobb

Role: CONTACT

Jessica.Cobb@surgery.ufl.edu

352-273-7837

Facility Contacts

Jessica Cobb

Role: primary

Jessica.Cobb@surgery.ufl.edu

352-273-7837

Other Identifiers

IRB202001646

Identifier Type: -

Identifier Source: org_study_id