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Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning (Endoth-Exvivo)

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ClinicalTrials.gov Identifier: NCT03987113
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale Rouen U1096
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

The study population will be patients with planned double-lung transplant, with preoperative ex-vivo reconditioning procedure.

The ex-vivo procedure will be performed for lungs considered as limit to be directly implanted according to the national classification or in case of Maastrich 3 decision. They required a rehabilitation procedure like ex-vivo to determine their quality. Once the procedure initiated, the unused remaining liquid will be retrieved for the first gasometry usually performed. This will be the time T1 of sampling.

The unused remaining liquid will be retrieved for the gasometry of end of procedure usually performed, before the graft cooling. This will be the time T2.

The purge liquid of first lung at the declamping of the pulmonary artery will be retrieved at the time of unclamping (time T3 of sampling).

The purge liquid of the second lung at the declamping of the pulmonary artery will be retrieved with the same procedure (time T4 of sampling).

The samples will be analysed with ELISA technique. The endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.


Condition or disease Intervention/treatment
Lung Transplant Other: Plasma concentration analysis during and after ex-vivo pulmonary reconditioning

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Intervention Details:
  • Other: Plasma concentration analysis during and after ex-vivo pulmonary reconditioning
    The pulmonary endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.


Primary Outcome Measures :
  1. Correlation between time of cold ischemia and endothelial dysfunction [ Time Frame: 24 hours ]
    Plasma concentration in heparin sulphate, syndecan-1, endothelin-1 and i-NOS


Secondary Outcome Measures :
  1. Correlation between time of cold ischemia and systemic inflammation [ Time Frame: 24 hours ]
    Plasma concentration in IL-1β, IL-8, IL-10 and TNF-α



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who requires a lung transplant, with ex-vivo reconditioning procedure. The objective is to create a plasma bank for all these patients with post analysis of sample.
Criteria

Selection Criteria:

  • patient aged > 18 years old
  • patient with healthcare insurance
  • non-opposition of the patient
  • patient with usual criteria for lung transplant and planned lung transplant after meeting of staff transplant

Non Selection Criteria:

  • participation refusal
  • patient under tutorship or guardianship
  • protected adult

Inclusion Criteria:

  • selected patient with Biomedecine Agency agreement for graft allocation off tour

Exclusion Criteria:

  • selected patient with Biomedicine Agency agreement for standard allocation graft

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 ClinicalTrials.gov identifier (NCT number): NCT03987113


Contacts
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Contact: Elisabeth Hulier-Ammar 33 146 25 11 75 drci-promotion@hopital-foch.com

Locations
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France
Hôpital Foch Active, not recruiting
Suresnes, France, 92150
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Morgan Le Guen    33 1 46 25 29 98    m.le-guen@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
Institut National de la Santé Et de la Recherche Médicale Rouen U1096
Investigators
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Principal Investigator: Morgan LE GUEN Anaesthesia department

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03987113     History of Changes
Other Study ID Numbers: 2017022F
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes