Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning (Endoth-Exvivo)

Hopital Foch

Status: Completed

Conditions: Lung Transplant

Treatments: Other: Plasma concentration analysis during and after ex-vivo pulmonary reconditioning

Study type: Observational

Funder types: Other

Identifiers

NCT03987113

2017022F

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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