Skip to main content
OpenTrials
Completed

NCT Number: NCT04616365

Planned Semi-Elective Lung Tx Study

In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Recipient inclusion criteria

  • Primary lung transplantation
  • Informed consent provided
  • 18-80 years old

Recipient exclusion criteria

  • Re-transplantation
  • Multi-organ transplantation
  • >80 years old

Donor inclusion criteria

  • Age ≤70 years old
  • Donor lungs are suitable to go straight to lung transplantation

Donor exclusion criteria

  • Age >70 years old
  • Concerns with organ preservation technique
  • Donor lungs require assessment by Ex Vivo Lung Perfusion (EVLP)

Treatment and study plan

Semi-Elective Lung Transplantation

Procedure

When suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h.

Primary outcomes

  1. Incidence of ISHLT Primary Graft Dysfunction Grade 3

    Time frame: 72 hours post-transplant

Secondary outcomes

  1. Overall survival

    Time frame: 30 days, 1 year post-transplant

  2. Time on ventilator

    Time frame: Perioperative

  3. ICU and hospital length of stay

    Time frame: Perioperative

  4. Occurrence of acute rejection

    Time frame: 1 year post-transplant

  5. Six minute walk test

    Time frame: 1 year post-transplant

  6. Forced expiratory volume - one second (FEV1 in L)

    Time frame: 1 year post-transplant

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 4, 2020
Registry last updated
Dec 28, 2023

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.

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