NCT04391920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 9, 2024

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

May 12, 2020

Last Update Submit

February 7, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    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 Outcomes (5)

  • Duration of ECMO after start of CytoSorb

    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

    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

    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

    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

    From the day before start of CytoSorb use until the day after cessation of CytoSorb use

Study Arms (1)

COVID-19 ICU Patients

Device: CytoSorb 300 mL device

Interventions

CytoSorb 300 mL deviceDEVICE

CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.

COVID-19 ICU Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 ICU patients receiving CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.

You may qualify if:

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

You may not qualify if:

  • CytoSorb therapy for diseases other than COVID-19
  • Survival unlikely within 24 hours (for prospectively enrolled patients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Baptist Memorial Hospital

Southaven, Mississippi, 38671, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

  • Hayanga JWA, Song T, Durham L, Garrison L, Smith D, Molnar Z, Scheier J, Deliargyris EN, Moazami N. Extracorporeal hemoadsorption in critically ill COVID-19 patients on VV ECMO: the CytoSorb therapy in COVID-19 (CTC) registry. Crit Care. 2023 Jun 19;27(1):243. doi: 10.1186/s13054-023-04517-3.

    PMID: 37337243DERIVED

  • 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.

    PMID: 34988092DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Nelson, MD

    CytoSorbents Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 18, 2020

Study Start

August 28, 2020

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 9, 2024

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(7)