Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning

Completed

• Conditions: Lung Transplant

• Registration Number: NCT03987113
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-14
• Status Verified: 2019-07
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• selected patient with Biomedicine Agency agreement for standard allocation graft

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France