Planned Semi-Elective Lung Tx Study

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04616365
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 28.2
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation	Procedure: Semi-Elective Lung Transplantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Planned Semi-Elective Lung Transplantation Using 10°C Cold Static Preservation: A Proof-Of-Concept Study
• Actual Study Start Date: Aug 26, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of ISHLT Primary Graft Dysfunction Grade 3 [72 hours post-transplant]

Secondary Outcome Measures

1. Overall survival [30 days, 1 year post-transplant]

2. Time on ventilator [Perioperative]

3. ICU and hospital length of stay [Perioperative]

4. Occurrence of acute rejection [1 year post-transplant]

5. Six minute walk test [1 year post-transplant]

6. Forced expiratory volume - one second (FEV1 in L) [1 year post-transplant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network (Toronto General Hospital)	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT04616365
• Other Study ID Numbers: 19-6364
• First Posted: Nov 4, 2020
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 17, 2021