Planned Semi-Elective Lung Tx Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Transplantation

Intervention / Treatment
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* Procedure: Semi-Elective Lung Transplantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-Elective Lung Transplantation<br>Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation | Procedure: Semi-Elective Lung Transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ISHLT Primary Graft Dysfunction Grade 3 |  | 72 hours post-transplant | 

Secondary Outcome Measures

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