We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 7 for:    ctc registry
Previous Study | Return to List | Next Study

Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04391920
Recruitment Status : Completed
First Posted : May 18, 2020
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
CytoSorbents Europe GmbH
Information provided by (Responsible Party):
CytoSorbents, Inc

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.

Condition or disease Intervention/treatment
COVID-19 Device: CytoSorb 300 mL device

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 30 Days
Official Title: Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients
Actual Study Start Date : August 28, 2020
Actual Primary Completion Date : January 20, 2022
Actual Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
COVID-19 ICU Patients Device: CytoSorb 300 mL device
CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ICU mortality [ Time Frame: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year ]

Secondary Outcome Measures :
  1. Duration of ECMO after start of CytoSorb [ Time Frame: From the date of start of CytoSorb use until the date of cessation of ECMO or date of death, which ever comes first, assessed up to 1 year ]
  2. Duration of mechanical ventilatory support after start of CytoSorb [ Time Frame: From the date of start of CytoSorb use until the date of cessation of mechanical ventilatory support or date of death, which ever comes first, assessed up to 1 year ]
  3. Duration of pharmacologic hemodynamic support after start of CytoSorb [ Time Frame: From the date of start of CytoSorb use until the date of cessation of pharmacologic hemodynamic support or date of death, which ever comes first, assessed up to 1 year ]
  4. Change in serum concentrations of inflammatory biomarkers after start of CytoSorb [ Time Frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use ]
  5. Change in Pa02/Fi02 ratio after start of CytoSorb [ Time Frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 ICU patients receiving CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
Criteria

Inclusion Criteria:

  1. Confirmed COVID-19
  2. Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.

Exclusion Criteria:

  1. CytoSorb therapy for diseases other than COVID-19
  2. Survival unlikely within 24 hours (for prospectively enrolled patients)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391920


Locations
Layout table for location information
United States, Colorado
Medical Center of Aurora
Aurora, Colorado, United States, 80012
United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
United States, Indiana
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
United States, Mississippi
Baptist Memorial Hospital
Southaven, Mississippi, United States, 38671
United States, New York
New York University Medical Center
New York, New York, United States, 10016
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
CytoSorbents, Inc
CytoSorbents Europe GmbH
Investigators
Layout table for investigator information
Study Director: Peter Nelson, MD CytoSorbents Corporation
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT04391920    
Other Study ID Numbers: 2020-001
FDA EUA ( Other Identifier: FDA )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases