CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

NCT05546606 | Active Not Recruiting

• 3 other identifiers: P150913J2022-A01343-40PHRC-15-557
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 20

Brief Summary

The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).

Conditions

COPD Acute Exacerbation

Keywords

ECCO2R; COPD

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  To determine the best strategy between strengthen standard of care reinforced with ECCO2R, versus single standard of care,

  Up to 60 days

Secondary Outcomes (14)

• Invasive Ventilator-free days (IVFDs)

  at 28 and 60 days

• Ventilator-free days (VFDs), including both IVFDs and non-invasive ventilator-free days (NIV-VFDs)

  at 28 and 60 days

• 28 day, 90 day, 180 day and 1 year all-cause mortality rate

  Up to 1 year

• Length of ECCO2R therapy

  Up to 28 days

• Proportion of patients without intubation and IMV (intubation and IMV avoided)

  Up to 28 days

Study Arms (2)

Single standard of care

NO INTERVENTION

COPD patients who require respiratory support for severe acute exacerbation (AE), either with NIV or with IMV.

Strengthen standard of care reinforced with ECCO2R

OTHER

COPD patients who require respiratory support for severe acute exacerbations (AE), either with NIV or with IMV reinforced with ECCO2R

Device: ECCO2R

Interventions

ECCO2R DEVICE

ECCO2R therapy using the Xenios platform, CE-marked medical device of the firm Xenios AG (Heilbronn, Germany), including the following components: Xenios console, iLA active iLA Kit IPS and Novaport Twin (18Fr, 22Fr or 24 Fr) cannulas The maximal duration of ECCO2R therapy with one circuit will be of 29 days in agreement with the regulatory approval of the patient kit.

Strengthen standard of care reinforced with ECCO2R

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
• Known or suspected diagnosis of COPD based on clinical history, pulmonary function test when available, arterial blood gases, physical examination, and chest radiograph
• Worsening dyspnea for \< 2 weeks
• Written informed consent signed by patients or their surrogates, with possibility of an emergency procedure with deferred consent
• Patient affiliated to a Social Security System (excluding "AME: aide médicale d'état")
• Negative serum or urinary β-hCG for women of child-bearing potential
• Very severe AE criteria defined either by:
• Stratum 1: high likelihood of NIV failure defined by PaCO2 \> 55 mmHg and pH \< 7.25, either at baseline and/or after at least one hour of NIV
• Stratum 2: intubation and IMV since less than 72 hrs, either after NIV failure and/or with pH \< 7.30 and PaCO2 \> 55 mmHg and PEEPi (end-expiratory occlusion) \> 5 cmH2O, while on Assist-Controlled Ventilation with the following parameters: VT: 8 ml/kg, RR: 12/min., applied PEEP: 0 cmH2O

You may not qualify if:

• Hemodynamic instability
• Known allergy to heparin or to any of the excipients of the specialty used
• Contra-indications to heparin listed in the SmPC of the specialty used.
• History of type II Heparin-induced thrombocytopenia
• Thrombocytopenia (platelets \< 100.000/mm3)
• Recent major surgery
• Haemorrhagic disorders such as:
• Organic lesion likely to bleed
• Bleeding manifestations or tendencies linked to disorders of hemostasis
• Intracerebral hemorrhage
• Uncontrolled arrhythmia
• Bleeding diathesis
• Body Mass Index \> 35 kg/m2
• PaO2/FiO2 \< 180 mmHg
• Do not intubate order

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• Xenios AG: collaborator

Study Sites (20)

CHU Angers

Angers, 49933, France

Location

CHU Besançon

Besançon, 25030, France

Location

Hôpital Avicennes, AP-HP

Bobigny, 93009, France

Location

CHD de Vendée

La Roche-sur-Yon, 85925, France

Location

CH Le Mans

Le Mans, 72000, France

Location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

Hôpital Nord

Marseille, 13015, France

Location

CHU Lapeyronie

Montpellier, 34295, France

Location

CHR Orléans

Orléans, 45067, France

Location

Hôpital La Pitié Salpêtrière, AP-HP

Paris, 75013, France

Location

Hôpital Cochin - APHP

Paris, 75014, France

Location

Hôpital européen Georges Pompidou - APHP

Paris, 75015, France

Location

Hôpital Tenon

Paris, 75020, France

Location

CHU la Milétrie

Poitiers, 86021, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

CHU Rouen

Rouen, 76031, France

Location

Centre Hospitalier de Saint Denis

Saint-Denis, 93200, France

Location

Nouvel Hôpital Civil Strasbourg

Strasbourg, 67091, France

Location

CHRU Bretonneau

Tours, 37044, France

Location

Hôpital d'Instruction des Armées Robert Picqué

Villenave-d'Ornon, 33882, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Luc MD Diehl, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, multi-centre, randomized, controlled, open-label

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: April 18, 2023
• Primary Completion: May 11, 2024
• Study Completion: March 11, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Locations

FR (20)