Planned Semi-Elective Lung Tx Study

University Health Network, Toronto

Status: Completed

Conditions: Lung Transplantation

Treatments: Procedure: Semi-Elective Lung Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04616365

19-6364

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Semi-Elective Lung Transplantation

Experimental group

Description:

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

Treatment:

Procedure: Semi-Elective Lung Transplantation