Clinical trial NCT04616365: Planned Semi-Elective Lung Tx Study
Official title: Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation: A Proof-Of-Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplantation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Incidence of ISHLT Primary Graft Dysfunction Grade 3
timeFrame: 72 hours post-transplant
Secondary outcomes:
measure: Overall survival
timeFrame: 30 days, 1 year post-transplant
measure: Time on ventilator
timeFrame: Perioperative
measure: ICU and hospital length of stay
timeFrame: Perioperative
measure: Occurrence of acute rejection
timeFrame: 1 year post-transplant
measure: Six minute walk test
timeFrame: 1 year post-transplant
measure: Forced expiratory volume - one second (FEV1 in L)
timeFrame: 1 year post-transplant
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Toronto
country: Canada
facility: University Health Network (Toronto General Hospital)
state: Ontario
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
Study officials:
affiliation: University Health Network, Toronto
name: Marcelo Cypel, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: