NCT04616365

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

August 25, 2020

Last Update Submit

December 27, 2023

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of ISHLT Primary Graft Dysfunction Grade 3

    72 hours post-transplant

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Semi-Elective Lung Transplantation

EXPERIMENTAL

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

Procedure: Semi-Elective Lung Transplantation

Interventions

Semi-Elective Lung TransplantationPROCEDURE

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.

Semi-Elective Lung Transplantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary lung transplantation
  • Informed consent provided
  • years old

You may not qualify if:

  • Re-transplantation
  • Multi-organ transplantation
  • \>80 years old
  • Age ≤70 years old
  • Donor lungs are suitable to go straight to lung transplantation
  • Age \>70 years old
  • Concerns with organ preservation technique
  • Donor lungs require assessment by Ex Vivo Lung Perfusion (EVLP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical University of Vienna

Vienna, Austria

Location

University Health Network (Toronto General Hospital)

Toronto, Ontario, M5G 2C4, Canada

Location

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, Spain

Location

Related Publications (2)

  • 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.

    PMID: 38499501DERIVED

  • 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.

    PMID: 38320127DERIVED

Study Officials

  • Marcelo Cypel, MD MSc

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

November 4, 2020

Study Start

August 26, 2020

Primary Completion

April 24, 2022

Study Completion

April 21, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations

AU(1)ES(1)CA(1)