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

NCT ID: NCT03987113

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-10-30

Brief Summary

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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

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Conditions

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Lung Transplant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale Rouen U1096

UNKNOWN

Sponsor Role collaborator

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgan LE GUEN

Role: PRINCIPAL_INVESTIGATOR

Anaesthesia department

Locations

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Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40738815 (View on PubMed)

Other Identifiers

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2017022F

Identifier Type: -

Identifier Source: org_study_id

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