Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation (EVLP-CHUM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02235610|
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplant||Procedure: EVLP Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
- Duration of mechanical ventilation [ Time Frame: 30 days after lung transplant ]How long it takes to disconnect the patient from mechanical ventilation
- 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
- 90 day Mortality [ Time Frame: 90 days after lung transplant ]Patient survival 90 days after lung transplantation
- 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)
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
|Contact: Ahmed Menaouar, PhD||514-890-8000 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Pasquale Ferraro, MD|
|Principal Investigator:||Pasquale Ferraro, MD||CHUM|