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

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant
• Intervention / Treatment: Other: Plasma concentration analysis during and after ex-vivo pulmonary reconditioning

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between time of cold ischemia and endothelial dysfunction	Plasma concentration in heparin sulphate, syndecan-1, endothelin-1 and i-NOS	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between time of cold ischemia and systemic inflammation	Plasma concentration in IL-1β, IL-8, IL-10 and TNF-α	24 hours

Collaborators and Investigators

• Sponsor: Hopital Foch
• Collaborators: Institut National de la Santé Et de la Recherche Médicale Rouen U1096
• Investigators: Principal Investigator: Morgan LE GUEN, Anaesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 2017022F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No