Planned Semi-Elective Lung Tx Study

Not Applicable

Recruiting

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

• Registration Number: NCT04601818
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Study Start: 2020-11-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1-year survival	procedure up to 1 year post op

Trial Locations

Locations (1)

UFHealth Shands; 🇺🇸 Gainesville, Florida, United States