Planned Semi-Elective Lung Tx Study

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616365
• Other study ID #: 19-6364
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: April 21, 2023

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 21, 2023
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Canada	University Health Network (Toronto General Hospital)	Toronto	Ontario
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Countries where clinical trial is conducted

Austria,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ISHLT Primary Graft Dysfunction Grade 3		72 hours post-transplant
Secondary	Overall survival		30 days, 1 year post-transplant
Secondary	Time on ventilator		Perioperative
Secondary	ICU and hospital length of stay		Perioperative
Secondary	Occurrence of acute rejection		1 year post-transplant
Secondary	Six minute walk test		1 year post-transplant
Secondary	Forced expiratory volume - one second (FEV1 in L)		1 year post-transplant