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

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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

Tracking Information
First Submitted Date May 12, 2020
First Posted Date May 18, 2020
Last Update Posted Date January 21, 2022
Actual Study Start Date August 28, 2020
Actual Primary Completion Date January 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2020)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: May 15, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of CytoSorb Therapy in COVID-19 ICU Patients
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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 30 Days
Biospecimen Not Provided
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.
Condition COVID-19
Intervention Device: CytoSorb 300 mL device
CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
Study Groups/Cohorts COVID-19 ICU Patients
Intervention: Device: CytoSorb 300 mL device
Publications * Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 20, 2022)
138
Original Estimated Enrollment
 (submitted: May 15, 2020)
1000
Actual Study Completion Date January 20, 2022
Actual Primary Completion Date January 20, 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04391920
Other Study ID Numbers 2020-001
FDA EUA ( Other Identifier: FDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party CytoSorbents, Inc
Original Responsible Party Same as current
Current Study Sponsor CytoSorbents, Inc
Original Study Sponsor Same as current
Collaborators CytoSorbents Europe GmbH
Investigators
Study Director: Peter Nelson, MD CytoSorbents Corporation
PRS Account CytoSorbents, Inc
Verification Date January 2022