Planned Semi-Elective Lung Tx Study

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplantation
• Intervention / Treatment: Procedure: Semi-Elective Lung Transplantation

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network (Toronto General Hospital)
• Spain
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro-Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: Semi-Elective Lung Transplantation; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Marcelo Cypel, MD MSc, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): April 24, 2022
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-6364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No