NCT04616365

Planned Semi-Elective Lung Tx Study

Completed NA Last updated 28 December 2023

What this trial tests

NA trial testing Semi-Elective Lung Transplantation in Lung Transplantation in 70 participants. Completed in 21 April 2023.

Timeline

26 August 2020

Primary endpoint
24 April 2022

21 April 2023

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	26 August 2020
Primary completion	24 April 2022
Estimated completion	21 April 2023
Sites	3 locations across Austria, Canada, Spain

Drugs / interventions tested

• Semi-Elective Lung Transplantation

Conditions studied

• Lung Transplantation — all drugs for Lung Transplantation →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 80, any sex, with Lung Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extension of Cold Static Donor Lung Preservation at 10°C.
   Ali A, Hoetzenecker K, Luis Campo-Cañaveral de la Cruz J, Schwarz S, et al · · 2023 · cited 57× · PMID 38320127 · DOI 10.1056/evidoa2300008
2. Successful 3-day lung preservation using a cyclic normothermic ex vivo lung perfusion strategy.
   Ali A, Nykanen AI, Beroncal E, Brambate E, et al · · 2022 · cited 36× · PMID 35952495 · DOI 10.1016/j.ebiom.2022.104210
3. Prolonged Preservation of up to 24 Hours at 10 °C Does Not Impact Outcomes after Lung Transplantation.
   Hoetzenecker K, Ali A, Campo-Cañaveral de la Cruz J, Schwarz S, et al · · 2025 · cited 10× · PMID 39817344 · DOI 10.1097/sla.0000000000006632
4. Donor lung preservation for transplantation-where do we go from here?
   Van Raemdonck D, Van Slambrouck J, Ceulemans LJ. · · 2022 · cited 8× · PMID 36245629 · DOI 10.21037/jtd-22-949
5. Successful sequential transplantation of 2 single lungs from the same donor into 2 different recipients-use of standard cold preservation and 10 °C preservation.
   Barr J, Ali A, Kawashima M, Keshavjee S, et al · · 2022 · cited 2× · PMID 35711178 · DOI 10.1016/j.xjtc.2022.03.019
6. A successful 24-hour preservation for human lung lobar transplantation leveraging 10 ° cold storage and ex vivo lung perfusion.
   Aragaki M, Inage T, Kawashima M, Taniguchi D, et al · · 2024 · cited 1× · PMID 39156527 · DOI 10.1016/j.xjtc.2024.04.006
7. What is the current state of clinical evidence for static lung preservation devices, and is it sufficient to inform clinical practice?
   Rodrigues ALSO, Reis FPD, Cabral TDD, Dos Santos SL, et al · · 2026 · PMID 41967306 · DOI 10.1016/j.clinsp.2026.100909