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

NCT03987113 | Completed

• 1 other identifier: 2017022F
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant

Outcome Measures

Primary Outcomes (1)

• Correlation between time of cold ischemia and endothelial dysfunction

  Plasma concentration in heparin sulphate, syndecan-1, endothelin-1 and i-NOS

  24 hours

Secondary Outcomes (1)

• Correlation between time of cold ischemia and systemic inflammation

  24 hours

Interventions

Plasma concentration analysis during and after ex-vivo pulmonary reconditioning OTHER

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• selected patient with Biomedicine Agency agreement for standard allocation graft

Sponsors & Collaborators

• Hopital Foch: lead
• Institut National de la Santé Et de la Recherche Médicale Rouen U1096: collaborator

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (1)

• Selim J, Wolf J, Soulie M, Sage E, Glorion M, Fessler J, Mulder P, Vasse M, Bellien J, Djerada Z, Richard V, Guen ML. Post-Ex Vivo Lung Perfusion Hypothermic Storage Limits Inflammation and Endothelial Dysfunction. J Cardiothorac Vasc Anesth. 2025 Oct;39(10):2748-2759. doi: 10.1053/j.jvca.2025.07.007. Epub 2025 Jul 8.

  PMID: 40738815 DERIVED

Study Officials

• Morgan LE GUEN

  Anaesthesia department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 14, 2019
• Study Start: November 15, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: July 14, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)