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Could a CO2-Removal device save lives in severe COPD attacks?

NCT ID NCT05546606

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates whether adding a device that removes carbon dioxide from the blood (ECCO2R) to standard care improves survival in people with very severe flare-ups of chronic obstructive pulmonary disease (COPD). The study includes patients at high risk of needing a breathing tube or already on a ventilator. Researchers compare outcomes between those receiving standard care alone and those also receiving ECCO2R therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ECCO2R therapy using the Xenios platform (a device that removes carbon dioxide from the blood)
What this could lead to
If effective, this approach could reduce the need for invasive ventilation and lower death rates during severe COPD flare-ups.
What could go wrong
This is a very small, early-stage study with only 17 participants, so results may not apply broadly. The device carries risks like bleeding, infection, and blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

17 people

The number who actually took part.

Started

Apr 2023

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. 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 2. 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 Exclusion Criteria: * 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 * Fibrosing idiopathic interstitial pneumonitis (based on the available medical files) * Neuromuscular diseases (based on the available medical files) * Patients with tracheotomy * Patients with severe concomitant chronic systemic disease with a limited probability of survival (\< 6 months) * Severely disabled (confinement to bed and inability to wash or dress alone) patients before AE * Pregnant woman * Participation in another interventional study involving human participants up to their ICU discharge, whether the studies include an investigational medical device, or being in the exclusion period at the end of a previous study.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD acute exacerbation

Contacts and locations

Locations

  • CH Le Mans

    Le Mans, 72000, France

  • CHD de Vendée

    La Roche-sur-Yon, 85925, France

  • CHR Orléans

    Orléans, 45067, France

  • CHRU Bretonneau

    Tours, 37044, France

  • CHU Angers

    Angers, 49933, France

  • CHU Besançon

    Besançon, 25030, France

  • CHU Lapeyronie

    Montpellier, 34295, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • CHU Rouen

    Rouen, 76031, France

  • CHU la Milétrie

    Poitiers, 86021, France

  • Centre Hospitalier de Saint Denis

    Saint-Denis, 93200, France

  • Hôpital Avicennes, AP-HP

    Bobigny, 93009, France

  • Hôpital Cochin - APHP

    Paris, 75014, France

  • Hôpital La Pitié Salpêtrière, AP-HP

    Paris, 75013, France

  • Hôpital Nord

    Marseille, 13015, France

  • Hôpital Tenon

    Paris, 75020, France

  • Hôpital d'Instruction des Armées Robert Picqué

    Villenave-d'Ornon, 33882, France

  • Hôpital de la Croix-Rousse

    Lyon, 69317, France

  • Hôpital européen Georges Pompidou - APHP

    Paris, 75015, France

  • Nouvel Hôpital Civil Strasbourg

    Strasbourg, 67091, France

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