This trial is active, not recruiting.

Condition neurogenic lung edema
Treatment carbone monoxide
Sponsor University Hospital of Mont-Godinne
Start date January 2014
End date January 2018
Trial size 40 participants
Trial identifier NCT02032082, EVLP-CO


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
(No Intervention)
During the Ex Vivo Lung Perfusion reconditioning,the lungs will be ventilated wit h Oxygen (21%) and Carbon Monoxide (250ppm).
carbone monoxide

Primary Outcomes

Incidence on Primary Graft Dysfunction
time frame: Up to 2 years

Eligibility Criteria

Male or female participants from 5 years up to 65 years old.

Inclusion Criteria: Lung Edema Exclusion Criteria: Infection Severe Emphysema Tumor

Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Hospital of Mont-Godinne.