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OpenTrials
Completed

NCT Number: NCT03987113

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

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.

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Key information

Conditions

Lung Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Collaborators

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

Registry information

Acronym: Endoth-Exvivo

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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