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Clinical Trials in France / NCT05664204
Recruiting Not applicable

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

NCT05664204 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2024-02-29
Last updated
2024-05-16

Condition(s) studied

The Number of Ventilator-free Days in the 28 Days Following LT

Investigational drug(s) / intervention(s)

Veno-arterial extracorporeal membrane oxygenation

Veno-arterial extracorporeal membrane oxygenation: Strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events

Study summary

In patients undergoing lung transplantation (LT), the investigators hypothesize that a "systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an "on-demand" intraoperative ECMO strategy.

To date, LT remains a highly hazardous procedure. Even if the surgical procedure is well established, the intraoperative support is not, and most intra-operative ECMO decisions rely on local protocols, anesthesiologists' habits, and surgeons' preference.

The efficacy of applying a "systematic" strategy on reducing the occurrence of severe primary graft dysfunction and thus mechanical ventilation in the 28 days following LT, without increasing mortality or morbidity, would support future guidelines on the use of ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The number of ventilator-free days — The 28 days following LT
    Assess the efficacy of a systematic, pre-operative VA-ECMO strategy on increasing ventilator-free days in the 28 days following LT

Trial sites (2)

FacilityCityRegionStatus
Hôpital Bichat Claude Bernard Paris France Recruiting
Hôpital FOCH Suresnes France Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05664204 on ClinicalTrials.gov ↗ ← All trials in France