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Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning

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. Read our disclaimer for details. Identifier: NCT02032082
Recruitment Status : Unknown
Verified March 2016 by Asmae Belhaj, University Hospital of Mont-Godinne.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2014
Last Update Posted : March 15, 2016
Information provided by (Responsible Party):
Asmae Belhaj, University Hospital of Mont-Godinne

Brief Summary:

Ex vivo lung perfusion (EVLP) is not a new concept and has been widely used to study lung function in small animals. It also has been shown to be a useful technique to evaluate lungs from donation after cardiac death (DCD) (Yeung, Thorac Surg Clin, 2009). It has been recently demonstrated successful application of an acellular EVLP technique in optimalizing lung function ex vivo for an extended period of time. Following 12 h of normothermic EVLP, patients were transplanted and demonstrated immediate life-sustaining function with promising short-term evolution (Aigner, Am J Transplant, 2012; Sanchez, J Heart Lung Transplant, 2012; Cypel, N Engl J Med, 2011).

Lung donation obtained after carbon monoxide intoxication has been recognized as excellent organs because of less general inflammation and less primary graft dysfunction after procedure. In a murine model of brain dead, carbon monoxide inhalation at a low concentration (50 to 500 parts per million (ppm)) exerts significant cytoprotection in several lung injury models via its vasodilatation, anti-inflammatory, and anti-apoptotic properties (Dong, J Heart Lung transplant, 2010). The carbon monoxide inhalation down-regulates pro-inflammatory cytokines (TNF-alpha, IL-6) along with the increase of anti-inflammatory cytokine (IL-10) in recipient serum. The inhalation significantly decreases cell apoptosis in lung grafts, inhibiting mRNA and protein expression of intercellular adhesion molecule-1 (ICAM-1) and caspase-3 in lung grafts (Zhou, Chin Med J, 2008).

Apoptotis and inflammatory processes may, in part, concern alveolar tissue. Research in the field of biomarkers is now opening new perspectives with the development of non-invasive tests allowing for monitoring inflammation and damage in the deep lung. Blood tests (Bernard, Toxicol Appl Pharmacol, 2005) measuring lung-specific proteins (pneumoproteins) such as Clara cell protein (CC16) and surfactant-associated proteins (A, B or D) are now available to evaluate the permeability and/or the cellular integrity of the pulmonary epithelium. These dosages may constitute an interesting way for monitoring the quality of the lung before implantation.

Condition or disease Intervention/treatment Phase
Neurogenic Lung Edema Other: Carbone monoxide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Study Start Date : January 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
No Intervention: Ex vivo without CO
Experimental: EX Vivo with carbone monoxide
During the Ex Vivo Lung Perfusion reconditioning,the lungs will be ventilated wit h Oxygen (21%) and Carbon Monoxide (250ppm).
Other: Carbone monoxide

Primary Outcome Measures :
  1. Incidence on Primary Graft Dysfunction [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Lung Edema

Exclusion Criteria:

Infection Severe Emphysema Tumor

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 identifier (NCT number): NCT02032082

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CHU Mont-Godinne
Yvoir, Namur, Belgium, 5530
Sponsors and Collaborators
University Hospital of Mont-Godinne

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Responsible Party: Asmae Belhaj, MD, University Hospital of Mont-Godinne Identifier: NCT02032082    
Other Study ID Numbers: EVLP-CO
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Pulmonary Edema
Lung Diseases
Respiratory Tract Diseases