Lung TransplantEndoth-ExvivoNCT03987113
Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
An observational study of Lung Transplant, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Plasma concentration analysis during and after ex-vivo pulmonary reconditioning
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2018to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who requires a lung transplant, with ex-vivo reconditioning procedure. The objective is to create a plasma bank for all these patients with post analysis of sample.
Who may be able to join
- selected patient with Biomedecine Agency agreement for graft allocation off tour
Who cannot join
- selected patient with Biomedicine Agency agreement for standard allocation graft
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Lung Transplant
- Being tested
- Plasma concentration analysis during and after ex-vivo pulmonary reconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma concentration analysis during and after ex-vivo pulmonary reconditioningOther
The pulmonary endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between time of cold ischemia and endothelial dysfunction
Plasma concentration in heparin sulphate, syndecan-1, endothelin-1 and i-NOS
Measured: 24 hours
Secondary outcomes (1)
Correlation between time of cold ischemia and systemic inflammation
Plasma concentration in IL-1β, IL-8, IL-10 and TNF-α
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start15 Nov 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale Rouen U1096
- Responsible party
- Sponsor
- Investigators
- Morgan LE GUEN, Principal investigator, Anaesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987113
- Sponsor's protocol ID
- 2017022F
- Acronym
- Endoth-Exvivo
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selim J, Wolf J, Soulie M, Sage E, Glorion M, Fessler J, Mulder P, Vasse M, Bellien J, Djerada Z, Richard V, Guen ML. Post-Ex Vivo Lung Perfusion Hypothermic Storage Limits Inflammation and Endothelial Dysfunction. J Cardiothorac Vasc Anesth. 2025 Oct;39(10):2748-2759. doi: 10.1053/j.jvca.2025.07.007. Epub 2025 Jul 8.
PubMed 40738815
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
- ClinicalTrials.gov ID
- NCT03987113
- Acronym / sponsor ID
- Endoth-Exvivo / 2017022F
- Conditions
- Lung Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale Rouen U1096
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who requires a lung transplant, with ex-vivo reconditioning procedure. The objective is to create a plasma bank for all these patients with post analysis of sample.
Key inclusion criteria (1 listed)
- selected patient with Biomedecine Agency agreement for graft allocation off tour
Key exclusion criteria (1 listed)
- selected patient with Biomedicine Agency agreement for standard allocation graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma concentration analysis during and after ex-vivo pulmonary reconditioningThe pulmonary endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS. | Other | – |
Primary outcome
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
1 secondary outcome
Correlation between time of cold ischemia and systemic inflammation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 40738815Selim J, Wolf J, Soulie M, Sage E, Glorion M, Fessler J, Mulder P, Vasse M, Bellien J, Djerada Z, Richard V, Guen ML. Post-Ex Vivo Lung Perfusion Hypothermic Storage Limits Inflammation and Endothelial Dysfunction. J Cardiothorac Vasc Anesth. 2025 Oct;39(10):2748-2759. doi: 10.1053/j.jvca.2025.07.007. Epub 2025 Jul 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan LE GUEN principal investigator
Anaesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between time of cold ischemia and endothelial dysfunction (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.