Back to resultsPost-Market Study of Low-flow ECCO2R Using PrismaLung+
Primary Purpose
Mild to Moderate Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PrismaLung+
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patient age is ≥ 18 years old
- Patient is expected to receive ECCO2R for a minimum of 24 hours
Patient has mild or moderate ARDS according to the Berlin definition:
- 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and
- Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and
- Respiratory failure not fully explained by cardiac failure or fluid overload
- Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent.
Exclusion Criteria:
- Patients body weight < 30 kg
- Patients with a contraindication for systemic anticoagulation with heparin
- Patients with a platelet count < 50,000/µL
- Patients on MV > 7 days
- Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
- Current or history of heparin-induced thrombocytopenia
- Patients who are pregnant and/or breastfeeding
- Patients not expected to survive the duration of the planned study treatment period (24 hours)
- Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
Sites / Locations
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Total Patient Population
Arm Description
The planned PrismaLung+ treatment period for this study is 24 hours. Neuromuscular blockade and sedation will be required for the first 24 hours of ECCO2R treatment and thereafter, will be used at the discretion of the attending physician. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Blood warming during ECCO2R treatment will occur using the TherMax blood warmer.
Outcomes
Primary Outcome Measures
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation
Must maintain PaCO2 < 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight.
Adverse Events related to study device
Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device.
This definition includes any event resulting from use error or from intentional misuse of the study device.
Adverse Events related to study procedure
Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device.
Adverse Device Effect (ADE)
This includes study device and study procedure related adverse events.
Adverse Events leading to study withdrawal
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal.
Adverse events of special interest (AESIs)
The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE).
Secondary Outcome Measures
Full Information
NCT ID
NCT04617093
First Posted
October 30, 2020
Last Updated
August 1, 2023
Sponsor
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04617093
Brief Title
Post-Market Study of Low-flow ECCO2R Using PrismaLung+
Official Title
A Post-Market Study of Performance and Safety of Low-flow Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Patients With Mild to Moderate Acute Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLung+. The study will assess tidal volume reduction and confirm the safety of PrismaLung+.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Patient Population
Arm Type
Experimental
Arm Description
The planned PrismaLung+ treatment period for this study is 24 hours. Neuromuscular blockade and sedation will be required for the first 24 hours of ECCO2R treatment and thereafter, will be used at the discretion of the attending physician. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Blood warming during ECCO2R treatment will occur using the TherMax blood warmer.
Intervention Type
Device
Intervention Name(s)
PrismaLung+
Intervention Description
Overall, 50 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as stand-alone therapy and another minimum of approximately 15 patients (maximum of 20) will receive ECCO2R using PrismaLung+ in combination with CRRT.
Primary Outcome Measure Information:
Title
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation
Description
Must maintain PaCO2 < 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight.
Time Frame
8 and 24 hours following ECCO2R initiation
Title
Adverse Events related to study device
Description
Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device.
This definition includes any event resulting from use error or from intentional misuse of the study device.
Time Frame
Day 1 to Day 28
Title
Adverse Events related to study procedure
Description
Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device.
Time Frame
Day 1 to Day 28
Title
Adverse Device Effect (ADE)
Description
This includes study device and study procedure related adverse events.
Time Frame
Day 1 to Day 28
Title
Adverse Events leading to study withdrawal
Description
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal.
Time Frame
Day 1 to Day 28
Title
Adverse events of special interest (AESIs)
Description
The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE).
Time Frame
Day 1 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient age is ≥ 18 years old
Patient is expected to receive ECCO2R for a minimum of 24 hours
Patient has mild or moderate ARDS according to the Berlin definition:
100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and
Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and
Respiratory failure not fully explained by cardiac failure or fluid overload
Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent.
Exclusion Criteria:
Patients body weight < 30 kg
Patients with a contraindication for systemic anticoagulation with heparin
Patients with a platelet count < 50,000/µL
Patients on MV > 7 days
Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
Current or history of heparin-induced thrombocytopenia
Patients who are pregnant and/or breastfeeding
Patients not expected to survive the duration of the planned study treatment period (24 hours)
Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baxter Clinical Trials Disclosure Call Center
Phone
(224) 948-7359
Email
Global_CORP_ClinicalTrialsDisclosure@baxter.com
Facility Information:
Facility Name
Baxter Investigational Site
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Colombes
ZIP/Postal Code
92700
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Post-Market Study of Low-flow ECCO2R Using PrismaLung+
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