COPDPALP-COPDNCT02107222
The PALP™-COPD Trial (Low-Flow CO2-Removal (ECCO2-R) in Exacerbated COPD)
A study testing CO2-Removal (PALP-Device/MaquetCP) in people with COPD and Chronic Obstructive Pulmonary Disease, run by Maquet Cardiopulmonary GmbH at 1 site in Germany.
Trial summary
A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients with COPD Exacerbation and Respiratory Failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- CO2-Removal (PALP-Device/MaquetCP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento Dec 2016
- 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
- Male or female, and ≥40 years of age
- Known history of COPD
- Currently experiencing an exacerbation of COPD
- P/F ratio >150 mmHg
- Currently endotracheally intubated and requiring invasive mechanical ventilation (must have been on invasive mechanical ventilation for 24-48 hours)
- Able to tolerate large bore intravenous (IV) cannulation required for proper operation of study device
- For female patients of child-bearing potential, a negative urine or serum pregnancy test at screening; all female patients will be considered of child-bearing potential unless they are post menopausal for at least 1 year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- Written informed consent obtained according to local regulations; or, if unable to provide written informed consent due to incapacitation, a legally authorized representative is able to provide written informed consent on behalf of the patient
Who cannot join
- Any end-stage medical conditions with expected survival <6 months
- Tracheostomy
- Unable to provide central venous access
- Acute brain injury
- Any legally authorized document(s) that may restrict aggressive medical management such as "Do Not Resuscitate," "Do Not Intubate," etc.
- Risk of bleeding or clotting such as:
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- Known bleeding diathesis or abnormal clotting
- Recent or current use of medications known to increase risk of bleeding
- Screening platelet count of <75,000/mm3 or international normalized ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5 times the upper limit of normal (ULN) range for their respective laboratory values
- Any recognized contra indications to systemic anticoagulation therapy or use of heparin
- Body mass index (BMI) >35
- Any form of chronic hyperventilation not related to COPD
- Hemodynamic instability or requiring significant vasopressor support
- Cardiogenic or noncardiogenic pulmonary edema as the primary reason for respiratory failure
- High risk cardiac conditions
- Oxygen tension in arterial blood (PaO2) <50 mmHg via arterial blood gas (ABG) or any condition in which hypoxemia is a significant component of the respiratory failure
- Any other medical cause for acute respiratory failure not directly related to a COPD exacerbation
- Use of or treatment with an investigational drug, therapy, or device within 1 month (30 days) of baseline
- Female patients who are pregnant or breastfeeding
- Patients who are immuno-compromised
- Current active malignancy or history of malignancy within the past 5 years
- Patients in chronic dialysis
- Patients requiring extra-corporeal life support (ECLS) as a bridge to transplant
- Patients who, in the opinion of the investigator, would not be able to comply with the requirements of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Control Trial (RCT) to Determine Safety and Efficacy of PALP™ for ECCO2-R in Conjunction With Liberation From Mechanical Ventilation (MV) Compared to MV Alone in COPD Exacerbation and Respiratory Failure
A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients with COPD Exacerbation and Respiratory Failure
Read the detailed description
Primary Study Objectives
- To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation.
Secondary Study Objectives
- To evaluate the safety and tolerability of PALP™ in patients with an exacerbation of COPD requiring invasive mechanical ventilation.
- To determine if rates of adverse events (AEs) are reduced in patients who receive PALP™ and invasive mechanical ventilation vs invasive mechanical ventilation alone.
- To determine mortality rates in patients who receive PALP™ and invasive mechanical ventilation vs invasive mechanical ventilation alone.
- To determine if PALP™ will effectively reduce the number of subsequent acute decompensations requiring hospital admission for ventilatory support (invasive or noninvasive).
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- CO2-Removal (PALP-Device/MaquetCP)
- Keywords
- COPD, Exacerbation, invasive ventilation, CO2-Removal
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2-Removal (PALP-Device/MaquetCP)Device
extracorporeal circuit to remove CO2 out of the blood
| Study group | Role | What they receive |
|---|---|---|
| mechanical ventilation (MV) | No intervention | mechanical ventilation according to guidelines |
| MV + ECCO2-R(PALP-Device/MaquetCP) | Experimental | MV according to the guidelines plus CO2-Removal with PALP Receives: Device: CO2-Removal (PALP-Device/MaquetCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time of mechanical ventilation
- To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation.
Measured: 720 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Primary completionDec 2016 (estimated)
Why it stopped: This action is an internal decision that was not made because of any pending regulatory action for these products.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiopulmonary GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco V Ranieri, MD PhD, Principal investigator, Investigational institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107222
- Sponsor's protocol ID
- MAQ/COPD/PALP/2012
- Acronym
- PALP-COPD
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abrams DC, Brenner K, Burkart KM, Agerstrand CL, Thomashow BM, Bacchetta M, Brodie D. Pilot study of extracorporeal carbon dioxide removal to facilitate extubation and ambulation in exacerbations of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2013 Aug;10(4):307-14. doi: 10.1513/AnnalsATS.201301-021OC.
PubMed 23952848
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Control Trial (RCT) to Determine Safety and Efficacy of PALP™ for ECCO2-R in Conjunction With Liberation From Mechanical Ventilation (MV) Compared to MV Alone in COPD Exacerbation and Respiratory Failure
- ClinicalTrials.gov ID
- NCT02107222
- Acronym / sponsor ID
- PALP-COPD / MAQ/COPD/PALP/2012
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Exacerbation, invasive ventilation, CO2-Removal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This action is an internal decision that was not made because of any pending regulatory action for these products.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maquet Cardiopulmonary GmbHIndustry (pharma, biotech, devices)
- Primary completion
- Dec 2016 (estimated)
- First posted
- 8 Apr 2014 (estimated)
- 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.
A Multicenter, Randomized, Controlled Trial to Determine Safety and Efficacy of Pump Assisted Lung Protection (PALP™) for Low Flow Carbon Dioxide (CO2) Removal in Conjunction with Liberation from Mechanical Ventilation Compared to Mechanical Ventilation Alone in Patients with COPD Exacerbation and Respiratory Failure
Detailed description
Primary Study Objectives
- To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation.
Secondary Study Objectives
- To evaluate the safety and tolerability of PALP™ in patients with an exacerbation of COPD requiring invasive mechanical ventilation.
- To determine if rates of adverse events (AEs) are reduced in patients who receive PALP™ and invasive mechanical ventilation vs invasive mechanical ventilation alone.
- To determine mortality rates in patients who receive PALP™ and invasive mechanical ventilation vs invasive mechanical ventilation alone.
- To determine if PALP™ will effectively reduce the number of subsequent acute decompensations requiring hospital admission for ventilatory support (invasive or noninvasive).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mechanical ventilation (MV) | No intervention | –mechanical ventilation according to guidelines |
| MV + ECCO2-R(PALP-Device/MaquetCP) | Experimental | Device: CO2-Removal (PALP-Device/MaquetCP)MV according to the guidelines plus CO2-Removal with PALP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, and ≥40 years of age
- Known history of COPD
- Currently experiencing an exacerbation of COPD
- P/F ratio >150 mmHg
- Currently endotracheally intubated and requiring invasive mechanical ventilation (must have been on invasive mechanical ventilation for 24-48 hours)
Key exclusion criteria (24 listed)
- Any end-stage medical conditions with expected survival <6 months
- Tracheostomy
- Unable to provide central venous access
- Acute brain injury
- Any legally authorized document(s) that may restrict aggressive medical management such as "Do Not Resuscitate," "Do Not Intubate," etc.
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 |
|---|---|---|
| CO2-Removal (PALP-Device/MaquetCP)extracorporeal circuit to remove CO2 out of the blood | Device | MV + ECCO2-R(PALP-Device/MaquetCP) |
Primary outcome
Difference in time of mechanical ventilation
Time frame: 720 hours
• To evaluate the clinical effect of PALP™ in reducing the time on invasive ventilation in patients with an exacerbation of COPD requiring invasive mechanical ventilation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Results publication: PubMed 23952848Abrams DC, Brenner K, Burkart KM, Agerstrand CL, Thomashow BM, Bacchetta M, Brodie D. Pilot study of extracorporeal carbon dioxide removal to facilitate extubation and ambulation in exacerbations of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2013 Aug;10(4):307-14. doi: 10.1513/AnnalsATS.201301-021OC.
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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.
Marco V Ranieri, MD PhD principal investigator
Investigational institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2-Removal (PALP-Device/MaquetCP) in people with COPD and Chronic Obstructive Pulmonary Disease, run by Maquet Cardiopulmonary GmbH 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 8 inclusion and 24 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: withdrawn, as of the sponsor's last update on 1 Apr 2016. 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 withdrawn before enrolling participants, so there are no results.
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?
Difference in time of mechanical ventilation (time frame: 720 hours). 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 NCT02107222, which also lists 1 linked publication.
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 1 Apr 2016.