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

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ClinicalTrials.gov Identifier: NCT02235610
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Fondation Pour La Recherche en Chirurgie Thoracique De Montreal
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Institut de Recherches Cliniques de Montreal (IRCM)
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Lung Transplant Procedure: EVLP Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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Arm Intervention/treatment
No Intervention: Standard Group

Recipients receive standard donor lungs as per current clinical practice.

No experimental procedures will be carried out.

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

EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.

Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.





Primary Outcome Measures :
  1. Measure of survival [ Time Frame: 12 months after transplantation ]
    To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group


Secondary Outcome Measures :
  1. Evaluate primary graft dysfunction (PGD) [ Time Frame: 6h, 12h, 24h, 48h and 72h post-transplant ]
    PGD is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation

  2. Duration of hospital stay [ Time Frame: Expected average of 6 weeks ]
    Participants will be followed for the duration of hospital stay, an expected average of 6 weeks

  3. Duration of mechanical ventilation [ Time Frame: 30 days after lung transplant ]
    How long it takes to disconnect the patient from mechanical ventilation

  4. Quality of life (QoL) questionnaire [ Time Frame: The day that patients are added to transplant list, at 90 days and 1 year post transplantation ]
    Questions about Health and Well-Being of patient after lung transplantation

  5. 90 day Mortality [ Time Frame: 90 days after lung transplant ]
    Patient survival 90 days after lung transplantation


Other Outcome Measures:
  1. Biomarkers [ Time Frame: 1 hour pre- and up to 30 days post-transplant ]
    Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235610


Contacts
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Contact: Ahmed Menaouar, PhD 514-890-8000 ext 30785 ahmed.menaouar.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) - Hopital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Ahmed Menaouar, PhD    514-890-8000 ext 24608    ahmed.menaouar.chum@ssss.gouv.qc.ca   
Principal Investigator: Pasquale Ferraro, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fondation Pour La Recherche en Chirurgie Thoracique De Montreal
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Institut de Recherches Cliniques de Montreal (IRCM)
Investigators
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Principal Investigator: Pasquale Ferraro, MD CHUM

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02235610     History of Changes
Other Study ID Numbers: CE14.100
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Lung Transplantation
Ex Vivo Lung Perfusion
EVLP