Planned Semi-Elective Lung Tx Study

Not Applicable

Completed

• Conditions: Lung Transplantation
• Interventions: Procedure: Semi-Elective Lung Transplantation

• Registration Number: NCT04616365
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study Start: 2020-08-26
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Primary Completion: 2022-04-24
• Study Completion: 2023-04-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semi-Elective Lung Transplantation	Semi-Elective Lung Transplantation	Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation

Primary Outcome Measures

Name	Time	Method
Incidence of ISHLT Primary Graft Dysfunction Grade 3	72 hours post-transplant

Secondary Outcome Measures

Name	Time	Method
Six minute walk test	1 year post-transplant
ICU and hospital length of stay	Perioperative
Occurrence of acute rejection	1 year post-transplant
Overall survival	30 days, 1 year post-transplant
Time on ventilator	Perioperative
Forced expiratory volume - one second (FEV1 in L)	1 year post-transplant

Trial Locations

Locations (3)

Medical University of Vienna; 🇦🇹 Vienna, Austria

University Health Network (Toronto General Hospital); 🇨🇦 Toronto, Ontario, Canada

Hospital Universitario Puerta de Hierro-Majadahonda; 🇪🇸 Madrid, Spain