Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning (Endoth-Exvivo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03987113|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
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.
|Condition or disease||Intervention/treatment|
|Lung Transplant||Other: Plasma concentration analysis during and after ex-vivo pulmonary reconditioning|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning|
|Actual Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987113
|Contact: Elisabeth Hulier-Ammar||33 146 25 11 firstname.lastname@example.org|
|Hôpital Foch||Active, not recruiting|
|Suresnes, France, 92150|
|Suresnes, France, 92150|
|Contact: Morgan Le Guen 33 1 46 25 29 98 email@example.com|
|Principal Investigator:||Morgan LE GUEN||Anaesthesia department|