Clinical trial NCT02235610: Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation
Official title: Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant
Keywords: Lung Transplantation
Ex Vivo Lung Perfusion
EVLP
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Fondation Pour La Recherche en Chirurgie Thoracique De Montreal
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Institut de Recherches Cliniques de Montreal (IRCM)
First posted: 2014-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of survival
timeFrame: 12 months after transplantation
Secondary outcomes:
measure: Evaluate primary graft dysfunction (PGD)
timeFrame: 6h, 12h, 24h, 48h and 72h post-transplant
measure: Duration of hospital stay
timeFrame: Expected average of 6 weeks
measure: Duration of mechanical ventilation
timeFrame: 30 days after lung transplant
measure: Quality of life (QoL) questionnaire
timeFrame: The day that patients are added to transplant list, at 90 days and 1 year post transplantation
measure: 90 day Mortality
timeFrame: 90 days after lung transplant
Other outcomes:
measure: Biomarkers
timeFrame: 1 hour pre- and up to 30 days post-transplant
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: CHUM
name: Pasquale Ferraro, MD
role: PRINCIPAL_INVESTIGATOR
References: