COPD ExacerbationX-COPDNCT03584295

Early Extubation by ECCO2R Compared to IMV in Patients with Severe Acute Exacerbation of COPD

A study testing Extracorporeal carbon dioxide removal and Conventional Care in people with COPD Exacerbation, run by Xenios AG at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study aims to investigate if veno-venous (vv)-extracorporeal carbon dioxide Removal (ECCO2R) is capable of reducing mortality and/or severe disability at day 60 after randomisation in patients with severe acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring invasive mechanical ventilation… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COPD Exacerbation
What is being tested?: Extracorporeal carbon dioxide removal and Conventional Care
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: 7 Feb 2023to 25 Nov 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent signed and dated by the investigator; and
if patient is able to give consent: by the study patient
if patients unable to give consent: by the legal representative or
if an emergency situation is determined: by an independent consultant physician.
Minimum age of 18 years
In case of female patients:

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Postmenopausal status defined as I. Prior bilateral oophorectomy Or II. Age ≥60 years Or if Age is <60 years or cannot be determined
A negative pregnancy test, defined as negative beta hCG test with a hCG level <5 mIU/mL.
Known History of COPD
Acute exacerbation of COPD requiring invasive mechanical ventilation
Failed extubation attempt or extubation not possible within 24 hours after intubation
Acute and potentially reversible cause of respiratory failure as determined by the treating physician

Who cannot join

Any conditions which could interfere with the patient's ability to comply with the study
In case of female patients: pregnancy and lactation period
Participation in any interventional clinical study during the preceding 30 days
Platelets <70.000/µl at baseline
Previous participation in the X-COPD study
Endotracheally intubated and mechanically ventilated for >96 hours prior to randomization

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Acute liver failure, defined by an international normalized ratio (INR) >2 without anticoagulation and/or bilirubin >4 mg/dL (>68 μmol/L) and/or hepatic encephalopathy (all three apply)
PaO2/FiO2 ratio <120 mmHg measured with FiO2 of 1.0
Expectation of disease progression leading to high-flow extracorporeal membrane oxygenation (ECMO) treatment
Cerebral haemorrhage
Tracheostomy
Estimated life expectancy <6 months due to reasons other than COPD
Acute ischemic stroke
Contraindication to anticoagulation
Severe chronic liver disease (Child Pugh C)
Acute pulmonary embolism requiring thrombolytic therapy
Acute or chronic heart failure with left ventricular ejection fraction <30%
Acute or chronic renal failure requiring dialysis
Organ transplantation or immunosuppression due to ongoing immunosuppressive medication or neutropenia for instance following organ transplantation or anticancer therapy
Neuromuscular disorder or chronic restrictive lung disease affecting native lung ventilation
Known Heparin induced thrombocytopenia type II
Acute coronary syndrome and myocardial infarction
Obesity hypoventilation syndrome
BMI >40
Patient not expected to survive 48 hours
Do not resuscitate (DNR) order

Trial locations and contacts

1 site in 1 country.

Germany1 site

Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim
Cologne, 51109

Other trials in Germany

About this study

Official title: A Multicentre, Randomized-controlled Trial of EXtracorporeal CO2 Removal to Facilitate Early Extubation Compared to Invasive Mechanical Ventilation in Patients with Severe Acute Exacerbation of COPD (X-COPD)

Read the detailed description

The current study hypothesizes an advantage for veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) in severe acute exacerbation of COPD requiring invasive mechanical ventilation (IMV) to facilitate early extubation in terms of reducing mortality or severe disability. The study hypothesizes that avoiding IMV could reduce mortality and substantially improve quality of life, especially in regard to avoidance of tracheostomy and long-term home IMV. Improvement in mobility due to sooner recovery has a further major impact on patients' QoL.

After randomization patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated either with conventional care or VV-ECCO2R to facilitate early extubation. VV-ECCO2R is used in a standard configuration with either double lumen cannula (22-24Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-1.75 L/min.

Conventional care in the control arm includes invasive mechanical ventilation and the attempt to extubate the patient as early as possible and to switch to non-invasive ventilation (NIV). If extubation fails, tracheostomy can be performed according to the discretion of the treating physician.

Conditions: COPD Exacerbation
Being tested: Extracorporeal carbon dioxide removal, Conventional Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extracorporeal carbon dioxide removalDevice
Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation
Conventional CareOther
Patient with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional Care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.

Study groups in NCT03584295
Study group	Role	What they receive
Conventional care	Active comparator	Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician. Receives: Other: Conventional Care
Extracorporeal carbon dioxide removal	Experimental	Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R (Extracorporeal carbon dioxide removal) to facilitate early extubation. ECCO2R is used in a standard configuration with either double lumen cannula (22-24Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-1.75 L/min. Receives: Device: Extracorporeal carbon dioxide removal

What is being measured

The primary outcome is the main question the study is designed to answer.

Death or severe disability
Death or severe disability at day 60 after randomization, with severe disability defined as confinement to bed and/or inability to wash or dress alone and/or need for long-term invasive mechanical ventilation by day 60
Measured: day 60

Secondary outcomes (15)

Mortality or severe disability at day 180 after randomization
Change in mortality/severe disability rate
Measured: Day 180
Ventilator-associated pneumonia during ICU treatment
1. Some sign of respiratory distress, e.g., increased RR, increased FiO2
2. New or enlarging infiltrates on CXR
3. Culture of relevant organism from lung or major change in secretions from lung
Measured: up to 60 days
Reintubation rate
Number of reintubations
Measured: until day 180 after randomization
Days on IMV or noninvasive ventilation (NIV) or ECCO2R
defined as duration of total ventilatory support
Measured: up to 60 days
Thrombosis during treatment period
Thrombosis of major venous vessels during the treatment period
Measured: up to 29 Days
Quality of life of patient
Measured at day 60 and 180 after randomization, measured with Severe Respiratory Insufficiency and EQ-5D-5L Questionnaire
Measured: up to 180 days
Renal function
Worsening of renal function
Measured: up to 29 days
Mobility, measured with ActiGraph
Subgroup: Activity measurement with ActiGraph (at 1 centre)
Measured: up to 180 days
Treatment Cost
Total Treatment costs for the hospital stay
Measured: up to 180 days
Length of hospital stay
Change in days of hospital stay
Measured: Up to 180 Days
Need of tracheostomy
Change in rate of tracheostomy
Measured: Up to 180 Days
Breathing
Breathing through tracheostomy at day 60 after randomization
Measured: up to 60 days
Readmission
Readmission to hospital within 180 days after randomization
Measured: Up to 180 Days
Exacerbations
Number of exacerbations within 180 days after randomization
Measured: Up to 180 Days
Severe Bleeding
Defined as any bleeding event requiring administration of 1 unit of packed red cells, Detection of severe bleeding
Measured: up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 202325 Nov 2024

First posted12 Jul 2018
Study start7 Feb 2023
Primary completion1 Nov 2024
Study completion25 Nov 2024

Why it stopped: Business decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPD ExacerbationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03584295
Sponsor's protocol ID: COPD-ECCO2R-01-INT
Acronym: X-COPD
Status last verified: Mar 2025
First submitted: 25 Jun 2018
Last updated: 14 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CareCOPD - COPD Home Monitoring Study
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A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
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Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation

All COPD Exacerbation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Randomized-controlled Trial of EXtracorporeal CO2 Removal to Facilitate Early Extubation Compared to Invasive Mechanical Ventilation in Patients with Severe Acute Exacerbation of COPD (X-COPD)
ClinicalTrials.gov ID: NCT03584295
Acronym / sponsor ID: X-COPD / COPD-ECCO2R-01-INT
Conditions: COPD Exacerbation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision
Enrolment: 18 participants (actual)
Lead sponsor: Xenios AGIndustry (pharma, biotech, devices)
Collaborators: Winicker Norimed GmbH
Study start: 7 Feb 2023 (actual)
Primary completion: 1 Nov 2024 (actual)
Study completion: 25 Nov 2024 (actual)
First posted: 12 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional care	Active comparator	Other: Conventional CarePatients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.
Extracorporeal carbon dioxide removal	Experimental	Device: Extracorporeal carbon dioxide removalPatients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R (Extracorporeal carbon dioxide removal) to facilitate early extubation. ECCO2R is used in a standard configuration with either double lumen cannula (22-24Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-1.75 L/min.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Informed consent signed and dated by the investigator; and
Minimum age of 18 years
In case of female patients:
Known History of COPD
Acute exacerbation of COPD requiring invasive mechanical ventilation

Key exclusion criteria (26 listed)

Any conditions which could interfere with the patient's ability to comply with the study
In case of female patients: pregnancy and lactation period
Participation in any interventional clinical study during the preceding 30 days
Platelets <70.000/µl at baseline
Previous participation in the X-COPD study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extracorporeal carbon dioxide removalPatients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation	Device	Extracorporeal carbon dioxide removal
Conventional CarePatient with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional Care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.	Other	Conventional care

Primary outcome

Death or severe disability
Time frame: day 60
Death or severe disability at day 60 after randomization, with severe disability defined as confinement to bed and/or inability to wash or dress alone and/or need for long-term invasive mechanical ventilation by day 60

15 secondary outcomes

Mortality or severe disability at day 180 after randomization
Time frame: Day 180
Ventilator-associated pneumonia during ICU treatment
Time frame: up to 60 days
Reintubation rate
Time frame: until day 180 after randomization
Days on IMV or noninvasive ventilation (NIV) or ECCO2R
Time frame: up to 60 days
Thrombosis during treatment period
Time frame: up to 29 Days
Quality of life of patient
Time frame: up to 180 days
Renal function
Time frame: up to 29 days
Mobility, measured with ActiGraph
Time frame: up to 180 days
Treatment Cost
Time frame: up to 180 days
Length of hospital stay
Time frame: Up to 180 Days
Need of tracheostomy
Time frame: Up to 180 Days
Breathing
Time frame: up to 60 days
Readmission
Time frame: Up to 180 Days
Exacerbations
Time frame: Up to 180 Days
Severe Bleeding
Time frame: up to 60 days

Results and safety

The study was stopped early (reason given: Business decision). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Individual participant dataSharing planned: No

Related trials for COPD Exacerbation

RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruitingObservational study
CareCOPD - COPD Home Monitoring Study
Chronic Obstructive Pulmonary Disease
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Not yet recruitingPhase 4
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christian Karagiannidis, Prof. Dr. principal investigator

Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Extracorporeal carbon dioxide removal and Conventional Care in people with COPD Exacerbation, run by Xenios AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death or severe disability (time frame: day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.