Using ECMO to Improve Outcomes After Lung Transplantation

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

This study is testing if using a specific method of a heart-lung machine during lung transplants can help patients breathe better and need less mechanical ventilation in the weeks after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT05664204 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a systematic approach to using veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during lung transplantation to reduce the need for invasive mechanical ventilation in the first 28 days post-surgery. The study compares this systematic strategy to an on-demand approach, where ECMO is initiated based on specific hemodynamic and respiratory needs. By assessing the impact on ventilator-free days and the occurrence of severe primary graft dysfunction, the trial aims to establish guidelines for ECMO use in lung transplantation. The research is conducted at two hospitals in France, focusing on patients with obstructive or restrictive lung diseases.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are being assessed for bilateral sequential lung transplantation due to obstructive or restrictive lung diseases.

Not a fit: Patients with severe pulmonary hypertension or those undergoing lung transplantation for conditions like cystic fibrosis or active malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the need for mechanical ventilation and improve recovery outcomes for lung transplant patients.

How similar studies have performed: While ECMO is widely used, this systematic approach in lung transplantation is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Paris and 1 other locations

• Hôpital Bichat Claude Bernard — Paris, France (Recruiting)
• Hôpital FOCH — Suresnes, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Jonathan MESSIKA, MD — Hôpital FOCH
• Study coordinator: Jonathan MESSIKA, MD

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