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NCT05546606Terminated

CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Reason given: Early termination due to industry withdrawal

Brief summary (registry, in English)

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).

Status (registry)
Terminated
Study type
Interventional
Enrollment
17 (actual)
First submitted
15 Sept 2022
Start date
18 Apr 2023
Primary completion date
10 Jun 2024
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
COPD
NCT number
NCT05546606

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent major surgery
  • Patients with severe concomitant chronic systemic disease with a limited probability of survival (< 6 months)
  • 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.

Other illness

  • Known allergy to heparin or to any of the excipients of the specialty used
  • History of type II Heparin-induced thrombocytopenia
  • Haemorrhagic disorders such as:
    • Organic lesion likely to bleed
    • Bleeding manifestations or tendencies linked to disorders of hemostasis
    • Intracerebral hemorrhage
  • Uncontrolled arrhythmia
  • Bleeding diathesis
  • Fibrosing idiopathic interstitial pneumonitis (based on the available medical files)
  • Neuromuscular diseases (based on the available medical files)

Lab values

  • Thrombocytopenia (platelets < 100.000/mm3)

Other

  • Hemodynamic instability
  • Contra-indications to heparin listed in the SmPC of the specialty used.
  • Body Mass Index > 35 kg/m2
  • PaO2/FiO2 < 180 mmHg
  • Do not intubate order
  • Patients with tracheotomy
  • Severely disabled (confinement to bed and inability to wash or dress alone) patients before AE
  • Pregnant woman

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHU AngersAngersFranceUnknown status
CHU BesançonBesançonFranceUnknown status
Hôpital Avicennes, AP-HPBobignyFranceUnknown status
Chd de VendeeLa Roche-sur-YonFranceUnknown status
CH Le MansLe MansFranceUnknown status
Hôpital de la Croix RousseLyonFranceUnknown status
Hôpital NordMarseilleFranceUnknown status
CHU LapeyronieMontpellierFranceUnknown status
CHR OrléansOrléansFranceUnknown status
Hôpital Européen Georges Pompidou APHPParisFranceUnknown status
Hôpital Cochin APHPParisFranceUnknown status
Hôpital La Pitié Salpêtrière AP-HPParisFranceUnknown status
Hôpital TenonParisFranceUnknown status
CHU la MiletriePoitiersFranceUnknown status
CHU PontchaillouRennesFranceUnknown status
CHU RouenRouenFranceUnknown status
Centre Hospitalier de Saint-DenisSaint-DenisFranceUnknown status
Nouvel Hopital Civil StrasbourgStrasbourgFranceUnknown status
CHRU BretonneauToursFranceUnknown status
Hôpital d'Instruction des Armées Robert PicquéVillenave-d'OrnonFranceUnknown status

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