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

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CO2-Removal (PALP-Device/MaquetCP)
Sponsored by
Maquet Cardiopulmonary GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Exacerbation, invasive ventilation, CO2-Removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MAQUET Cardiopulmonary AG

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

mechanical ventilation (MV)

MV + ECCO2-R(PALP-Device/MaquetCP)

Arm Description

mechanical ventilation according to guidelines

MV according to the guidelines plus CO2-Removal with PALP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2014
Last Updated
March 31, 2016
Sponsor
Maquet Cardiopulmonary GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02107222
Brief Title
The PALP™-COPD Trial (Low-Flow CO2-Removal (ECCO2-R) in Exacerbated COPD)
Acronym
PALP-COPD
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
This action is an internal decision that was not made because of any pending regulatory action for these products.
Study Start Date
undefined (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maquet Cardiopulmonary GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Obstructive Pulmonary Disease
Keywords
COPD, Exacerbation, invasive ventilation, CO2-Removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mechanical ventilation (MV)
Arm Type
No Intervention
Arm Description
mechanical ventilation according to guidelines
Arm Title
MV + ECCO2-R(PALP-Device/MaquetCP)
Arm Type
Experimental
Arm Description
MV according to the guidelines plus CO2-Removal with PALP
Intervention Type
Device
Intervention Name(s)
CO2-Removal (PALP-Device/MaquetCP)
Intervention Description
extracorporeal circuit to remove CO2 out of the blood
Primary Outcome Measure Information:
Title
Difference in time of mechanical ventilation
Description
• 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.
Time Frame
720 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco V Ranieri, MD PhD
Organizational Affiliation
Investigational institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAQUET Cardiopulmonary AG
City
Rastatt
ZIP/Postal Code
76437
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23952848
Citation
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.
Results Reference
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The PALP™-COPD Trial (Low-Flow CO2-Removal (ECCO2-R) in Exacerbated COPD)

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