Clinical trial NCT05656404: TorEx Lung Perfusion System
Official title: Evaluation of the TorEx Lung Perfusion System in Clinical Lung Transplantation: A Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant
Ex Vivo Lung Perfusion
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lung transplantation is a life-saving and life-prolonging therapy for patients with end-stage lung disease. However, the number of patients listed for lung transplantation exceeds the number of available donor lungs, leading to long wait times, deterioration in health and death of some listed patients. One way to address this issue is to reduce the number of donor lungs that are deemed unusable (declined) for transplantation. Often, donor lungs are declined for transplantation based on questionable function or inability to fully assess the organ in the donor. Due to this reason, up to 80% of potentially suitable lungs may be discarded. As a result, ex vivo lung perfusion (EVLP) was developed.

EVLP is a technique that enables the donor lungs to function in near physiological conditions outside the body, allowing surgeons to evaluate the suitability of the donor lungs for transplantation. Using this technique, centers have reported the recovery of around 70% of donor lungs that would have otherwise been deemed unusable and discarded.

The first generation Toronto EVLP technique started as a clinical trial in 2008 and became a part of the clinical standard of care at Toronto General Hospital in 2011. Since then, many clinical studies have shown that short- and long-term outcomes of recipients who received donor lungs assessed by the Toronto EVLP system were similar to those who received donor lungs deemed suitable to go straight to transplantation.

In partnership with Traferox Technologies Inc., surgeons and research team members developed the second generation TorEx Lung Perfusion System, which addresses engineering design limitations of the original Toronto EVLP system. It optimizes the Toronto EVLP technique by combining all the necessary equipment required to perform the procedure, while placing their controls within a central location. The technique of perfusion and ventilation as well as the perfusate solution remain the same between the two EVLP systems. Prior to this study, the TorEx Lung Perfusion System has not been used in clinical human lung transplantation.

The first purpose of this study is to look at the safety of using the TorEx Lung Perfusion System in 20 consented recipients. The second purpose to compare post-transplant outcomes between recipients who received donor lungs assessed by the TorEx Lung Perfusion System and a historical cohort of recipients who received donor lungs that were assessed by the first generation Toronto EVLP system.


Eligibility criteria: Recipient Inclusion Criteria

* Actively listed for primary lung transplantation
* Written, informed consent provided
* 18-80 years old

Recipient Exclusion Criteria

* Re-transplantation
* Multi-organ transplantation
* Participation in another interventional trial

Donor Inclusion Criteria

* Age ≤70 years old
* Ex vivo lung perfusion clinically indicated for donor lungs

Donor Exclusion Criteria

* Age \>70 years old
* Donor lungs suitable to go straight to transplantation

EVLP Transplant Suitability

* Pulmonary vein PO2 \> 400mmHg
* Stability or improvement of other lung function parameters during EVLP (PVR, Compliance, Airway Pressures)
* Surgeon clinically satisfied with lung evaluation

Primary outcomes:
measure: Incidence of ISHLT Primary Graft Dysfunction Grade 3
timeFrame: 72 hours post-transplant
Secondary outcomes:
measure: Overall survival
timeFrame: 30 days, 1 year post-transplant
measure: Time on ventilator
timeFrame: Perioperative
measure: ICU and hospital length of stay
timeFrame: Perioperative
measure: Occurrence of acute rejection
timeFrame: 1 year post-transplant
measure: Six minute walk test
timeFrame: 1 year post-transplant
measure: Forced expiratory volume - one second (FEV1 in L)
timeFrame: 1 year post-transplant
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Laura Donahoe, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References: