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

Lung Transplant Clinical Trial

— Endoth-Exvivo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987113
• Other study ID #: 2017022F
• Status: Completed
• Start date: November 15, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: July 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Lung Transplant

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Foch	Institut National de la Santé Et de la Recherche Médicale Rouen U1096

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between time of cold ischemia and endothelial dysfunction	Plasma concentration in heparin sulphate, syndecan-1, endothelin-1 and i-NOS	24 hours
Secondary	Correlation between time of cold ischemia and systemic inflammation	Plasma concentration in IL-1ß, IL-8, IL-10 and TNF-a	24 hours