Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning

NCT02032082 | Unknown

• 1 other identifier: EVLP-CO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Lung Edema

Outcome Measures

Primary Outcomes (1)

• Incidence on Primary Graft Dysfunction

  Up to 2 years

Study Arms (2)

Ex vivo without CO

NO INTERVENTION

EX Vivo with carbone monoxide

EXPERIMENTAL

During the Ex Vivo Lung Perfusion reconditioning,the lungs will be ventilated wit h Oxygen (21%) and Carbon Monoxide (250ppm).

Other: Carbone monoxide

Interventions

Carbone monoxide OTHER

EX Vivo with carbone monoxide

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung Edema

You may not qualify if:

• Infection Severe Emphysema Tumor

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (1)

CHU Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

BE (1)