The PALP™-COPD Trial (Low-Flow CO2-Removal (ECCO2-R) in Exacerbated COPD) (PALP-COPD)

March 31, 2016 updated by: Maquet Cardiopulmonary AG

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rastatt, Germany, 76437
        • MAQUET Cardiopulmonary AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, and ≥40 years of age
  2. Known history of COPD
  3. Currently experiencing an exacerbation of COPD
  4. P/F ratio >150 mmHg
  5. Currently endotracheally intubated and requiring invasive mechanical ventilation (must have been on invasive mechanical ventilation for 24-48 hours)
  6. Able to tolerate large bore intravenous (IV) cannulation required for proper operation of study device
  7. 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)
  8. 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

Exclusion Criteria:

  1. Any end-stage medical conditions with expected survival <6 months
  2. Tracheostomy
  3. Unable to provide central venous access
  4. Acute brain injury
  5. Any legally authorized document(s) that may restrict aggressive medical management such as "Do Not Resuscitate," "Do Not Intubate," etc.

  6. Risk of bleeding or clotting such as:

    • Known bleeding diathesis or abnormal clotting
    • Recent or current use of medications known to increase risk of bleeding
  7. 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
  8. Any recognized contra indications to systemic anticoagulation therapy or use of heparin
  9. Body mass index (BMI) >35
  10. Any form of chronic hyperventilation not related to COPD
  11. Hemodynamic instability or requiring significant vasopressor support
  12. Cardiogenic or noncardiogenic pulmonary edema as the primary reason for respiratory failure
  13. High risk cardiac conditions
  14. 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
  15. Any other medical cause for acute respiratory failure not directly related to a COPD exacerbation
  16. Use of or treatment with an investigational drug, therapy, or device within 1 month (30 days) of baseline
  17. Female patients who are pregnant or breastfeeding
  18. Patients who are immuno-compromised
  19. Current active malignancy or history of malignancy within the past 5 years
  20. Patients in chronic dialysis
  21. Patients requiring extra-corporeal life support (ECLS) as a bridge to transplant
  22. Patients who, in the opinion of the investigator, would not be able to comply with the requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: mechanical ventilation (MV)
mechanical ventilation according to guidelines
Experimental: MV + ECCO2-R(PALP-Device/MaquetCP)
MV according to the guidelines plus CO2-Removal with PALP
Device: CO2-Removal (PALP-Device/MaquetCP)
extracorporeal circuit to remove CO2 out of the blood

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
720 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maquet Cardiopulmonary AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco V Ranieri, MD PhD, Investigational institution

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAQ/COPD/PALP/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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