Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation (EVLP_MI)
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|ClinicalTrials.gov Identifier: NCT01967953|
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : October 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Disorder Related to Lung Transplantation Brain Death Graft Failure Primary Graft Dysfunction||Procedure: EVLP Group||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
No Intervention: Standard Group
Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria.
Events: lung procurement, cold storage on ice, transplantation.
Experimental: EVLP Group
Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP).
Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation.
Procedure: EVLP Group
EVLP technique: Steen solution; normothermia; low flow, open atrium, low hematocrit.
Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy
- Primary Graft Dysfunction 72 hours after lung transplantation (PGD72) [ Time Frame: 72 hours ]Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
- 30 day Mortality [ Time Frame: 30 days ]
- Duration of mechanical ventilation after transplantation [ Time Frame: 30 days ]
- ICU length of stay after transplantation [ Time Frame: 30 days ]
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): NCT01967953
|Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Principal Investigator:||Franco Valenza, MD||Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy|