Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation (EVLP-CHUM)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

Conditions: Lung Transplant

Treatments: Procedure: EVLP Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02235610

CE14.100

Details and patient eligibility

About

The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory molecules (biomarkers) that would benefit a successful pre-conditioning and increase knowledge of the lungs inflammatory response before transplantation.

Full description

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant centre to be perfused in our system by the transplant team. Perfusion of these lungs will be performed using evaluation solution with addition of red blood cells cross matched with the recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the normal transplantation criteria will be considered for transplantation. Lungs will be excluded for transplantation if the organs don't meet the normal transplantation criteria.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (aged 18 years and over).
• Patients already on or added to the active waiting list for first lung transplant.
• Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant.
• Patients' re-confirmation informed consent for the study on the day of the lung transplant.

Exclusion criteria

• Patients aged less than 18 years.
• Patients not providing informed consent for the study.
• Patients not in possession of patient information sheets for the study prior to the day of lung transplant.
• Patients' not re-confirming consent for the study on the day of lung transplant.
• Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard Group

No Intervention group

Description:

Recipients receive standard donor lungs as per current clinical practice. No experimental procedures will be carried out.

EVLP Group

Experimental group

Description:

Recipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered.

Treatment:

Procedure: EVLP Group