Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05664204

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-16

200

Participants Needed

2

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease
  • Affiliated to the French social security system
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Pulmonary hypertension with mean pulmonary arterial pressure over 45 mmHg
  • Pulmonary hypertension with echocardiographic evidence of right heart dysfunction (paradoxical septum, right ventricle dilation, or right ventricular ejection fraction under 35%)
  • Pre-capillary pulmonary hypertension with low cardiac output at right heart catheterization
  • Lung transplantation for primary pulmonary hypertension
  • Lung transplantation for cystic fibrosis and graft-versus-host disease
  • Re-do lung transplantation
  • Combined multi-organ transplantation
  • Active malignancy
  • Pregnancy or breastfeeding
  • Patients under legal guardianship (tutelle, curatelle, sauvegarde de justice)
  • Severe pulmonary hypertension with hemodynamic collapse on echocardiography
  • Lung transplantation patient under ECMO as bridge-to-transplantation
  • Preoperative hypoxemia with PaO2/FiO2 less than 80 mmHg
  • Preoperative hypercapnia with PaCO2 over 80 mmHg after induction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Hôpital Bichat Claude Bernard

Paris, France, 75018

Actively Recruiting

2

Hôpital FOCH

Suresnes, France, 92 150

Not Yet Recruiting

Loading map...

Research Team

J

Jonathan MESSIKA, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here