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Planned Semi-Elective Lung Tx Study

NCT04616365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-12-28

No results posted yet for this study

Summary

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.

Conditions

  • Lung Transplantation

Interventions

PROCEDURE

Semi-Elective Lung Transplantation

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Marcelo Cypel, MD MSc · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2022-04-24
Completion
2023-04-21

Countries

  • Austria
  • Canada
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04616365 on ClinicalTrials.gov