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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semi-Elective Lung Transplantation | Experimental | Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-Elective Lung Transplantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ISHLT Primary Graft Dysfunction Grade 3 | 72 hours post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 30 days, 1 year post-transplant | |
| Time on ventilator | Perioperative | |
| ICU and hospital length of stay |
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Recipient inclusion criteria
Recipient exclusion criteria
Donor inclusion criteria
Donor exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Cypel, MD MSc | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| University Health Network (Toronto General Hospital) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38499501 | Derived | Iskender I. Technical Advances Targeting Multiday Preservation of Isolated Ex Vivo Lung Perfusion. Transplantation. 2024 Jun 1;108(6):1319-1332. doi: 10.1097/TP.0000000000004992. Epub 2024 May 23. | |
| 38320127 | Derived | Ali A, Hoetzenecker K, Luis Campo-Canaveral de la Cruz J, Schwarz S, Barturen MG, Tomlinson G, Yeung J, Donahoe L, Yasufuku K, Pierre A, de Perrot M, Waddell TK, Keshavjee S, Cypel M. Extension of Cold Static Donor Lung Preservation at 10 degrees C. NEJM Evid. 2023 Jun;2(6):EVIDoa2300008. doi: 10.1056/EVIDoa2300008. Epub 2023 Apr 20. |
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|
| 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 |
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |
| Hospital Universitario Puerta de Hierro-Majadahonda | Madrid | Spain |