Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT05664204
Eligibility Criteria:
Inclusion Criteria:
Age \>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent
Exclusion Criteria:
At listing :
* a pulmonary hypertension with a mPAP \> 45 mmHg, including in the absence of haemodynamic collapse (MAP, LVEF, RV function all normal)
* a pulmonary hypertension with echocardiographic evidences of right heart dysfunction (paradoxical septum or RV dilatation or RVEF \< 35%)
* a pre-capillary pulmonary hypertension at right heart catheterization with low cardiac output
* LT for primary pulmonary hypertension
* LT for cystic fibrosis and graft-vs-host disease
* Re-do LT
* Combined multi-organ transplantation
* Active malignancy
* Pregnancy, breastfeeding
* Patients under guardianship (tutelle, curatelle, sauvegarde de justice)
Socondary exclusion criteria:
Patients without pulmonary hypertension or with pulmonary hypertension without right ventricular dilatation on an echocardiography in the last 6 months will be randomized; Patients meeting one of the following criteria will not be randomized and will be secondary excluded from the study :
* preoperative severe pulmonary hypertension with hemodynamic collapse on echocardiography defined by: paradoxical septum or dilatation of the right ventricle or RVEF \< 20LT in a patient under ECMO as bridge-to-transplantation
* PreLT hypoxemia with PaO2/FiO2 \< 80mmHg
* PreLT hypercapnia PaCO2 \> 80 mmHg after induction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05664204
Study Brief:
Protocol Section:
NCT05664204