RecruitingNot ApplicableNCT05664204

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

Veno-arterial Extracorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung Transplant: a Randomized Controlled Trial

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

200 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether placing patients on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) — a machine that takes over the heart and lung functions — during a double lung transplant can reduce complications and deaths. The study is aimed at patients with obstructive or restrictive lung disease who do not already have severe pulmonary hypertension. You may be eligible if... - You are over 18 years old - You are being assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease - You are affiliated with the French social security system - You have provided written informed consent You may NOT be eligible if... - You have severe pulmonary hypertension (mean pulmonary artery pressure above 45 mmHg) - You have evidence of right heart dysfunction on echocardiogram (paradoxical septum, right ventricle dilation, or RVEF below 35%) - You are having a lung transplant for primary pulmonary hypertension or cystic fibrosis with graft-vs-host disease - This would be a redo lung transplant or combined multi-organ transplant - You have an active malignancy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVeno-arterial extracorporeal membrane oxygenation

Strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events

Locations(2)

Hôpital Bichat Claude Bernard

Paris, France

Hôpital FOCH

Suresnes, France

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NCT05664204