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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03987113
Acronym
Endoth-Exvivo
Enrollment
20
Registered
2019-06-14
Start date
2018-11-15
Completion date
2019-10-30
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant

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.

Interventions

OTHERPlasma 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.

Sponsors

Institut National de la Santé Et de la Recherche Médicale Rouen U1096
CollaboratorUNKNOWN
Hopital Foch
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between time of cold ischemia and endothelial dysfunction24 hoursPlasma concentration in heparin sulphate, syndecan-1, endothelin-1 and i-NOS

Secondary

MeasureTime frameDescription
Correlation between time of cold ischemia and systemic inflammation24 hoursPlasma concentration in IL-1β, IL-8, IL-10 and TNF-α

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026