Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a specific type of support called "extra-corporeal membrane oxygenation" (ECMO) can help patients who are undergoing lung transplantation (LT). The researchers want to find out if using ECMO in a planned way during surgery can reduce the number of days patients need to rely on breathing machines (ventilators) in the first 28 days after the transplant, without causing more health problems or complications. This is important because lung transplantation can be risky, and improving the care during surgery could lead to better recovery for patients.

To be eligible for this trial, participants need to be over 18 years old and be assessed for a bilateral lung transplant for certain lung diseases. They also need to provide written consent to participate. The study is currently recruiting participants, and everyone, regardless of gender, is welcome to join. If you or someone you know is interested, they can expect to receive careful monitoring during and after the surgery. The findings from this trial could help shape future guidelines on how ECMO is used during lung transplants, potentially leading to better outcomes for patients.

Gender

ALL

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