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

NCT05664204 | Recruiting

• 2 other identifiers: APHP2110372022-A00538-35
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The number of ventilator-free days

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

  The 28 days following LT

Secondary Outcomes (15)

• The occurrence of grade III PGD

  The 72 hours following LT

• All-cause mortality

  Day-90 after LT

• Vital status

  Day-90 after LT

• Time-to-death from all causes

  The first year after LT

• The occurrence of ECMO-associated adverse event ; ECMO-associated adverse event defined as cannula infection, misplacement, intra-operative or per-ECMO air-embolism, limb ischemia, vascular complications, thrombophlebitis

  The 28 days following LT, Assessed daily from day-1 to day-90

Study Arms (2)

Systematic ECMO

EXPERIMENTAL

VA-ECMO will be implanted before the first pulmonary artery cross-clamp, in a systematic manner

Procedure: Veno-arterial extracorporeal membrane oxygenation

On-demand ECMO

ACTIVE COMPARATOR

VA-ECMO will be implanted intraoperatively, in an unplanned manner if the hemodynamic and respiratory indices meet pre-planned criteria at different time-points: a PaO2/FiO2 ratio\<100 mmHg or a respiratory acidosis, with pH\< 7.2, PaCO2\>60 mmHg, a mean pulmonary arterial pressure\>50mmHg (or 2/3 of MAP) and/or an acute pulmonal core at trans-esophageal echography monitoring an acute left ventricular dysfunction at trans-esophageal echography monitoring

Procedure: Veno-arterial extracorporeal membrane oxygenation

Interventions

Veno-arterial extracorporeal membrane oxygenation PROCEDURE

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

On-demand ECMO; Systematic ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Bichat Claude Bernard

Paris, 75018, France

RECRUITING

Hôpital FOCH

Suresnes, 92 150, France

NOT YET RECRUITING

Related Publications (1)

• Messika J, Eloy P, Boulate D, Charvet A, Fessler J, Jougon J, Lacoste P, Mercier O, Portran P, Roze H, Sage E, Thes J, Tronc F, Vourc'h M, Montravers P, Castier Y, Mal H, Mordant P; Investigators from the ECMOToP Study group. Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial. BMJ Open. 2024 Mar 5;14(3):e077770. doi: 10.1136/bmjopen-2023-077770.

  PMID: 38448059 DERIVED

MeSH Terms

Interventions

Extracorporeal Membrane Oxygenation

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Jonathan MESSIKA, MD

  Hôpital FOCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan MESSIKA, MD

CONTACT

+33 1 46 25 59 84; j.messika@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: February 29, 2024
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): September 28, 2027
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Up to two years after the last publication of the research results
• Access Criteria: IPD and any additional supporting information will be available on reasonable request from the corresponding author, for additional analyses such as -but not limited to- metaanalyses. The scientific advisory board of ECMOTOP study will assess the relevance of the request.

Locations

FR (2)