Skip to main content
OpenTrials
Completed

NCT Number: NCT04601818

Planned Semi-Elective Lung Tx 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UFHealth Shands

Gainesville, Florida, 32601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 72 hours post op

Secondary outcomes

  1. 1-year survival

    Time frame: procedure up to 1 year post op

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2020
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.