NCT02566525

Brief Summary

Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

8 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

September 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

September 28, 2015

Results QC Date

May 20, 2019

Last Update Submit

July 27, 2021

Conditions

Elective Cardiac Surgery

Keywords

CytoSorb devicePlasma free hemoglobininflammationextracorporeal bypass

Outcome Measures

Primary Outcomes (1)

  • Assessment of Serious Device Related Adverse Events

    The primary safety endpoint of this trial was to determine the product safety profile through the assessment of serious device related AEs through discharge from the ICU.

    From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)

Secondary Outcomes (3)

  • Time in the ICU

    From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)

  • 30 Day All Cause Mortality

    From time of enrollment through 30 days post procedure

  • Adverse Event Rates

    through 30 days

Other Outcomes (3)

  • Change in Complement Factor C3a - 2 Hours Post Start of CPB

    2 hours post start of cardiac bypass

  • Change in Complement Factor C3a - 3 Hours Post Start of CPB

    3 hours post start of CPB

  • Change in Complement Factor C5a - 2 Hours Post Start of CPB

    2 hours post start of cardiac bypass

Study Arms (2)

CytoSorb Device

EXPERIMENTAL

Standard of care plus treatment with CytSorb device installed on the CPB machine

Device: CytoSorb

Control

NO INTERVENTION

Standard of care

Interventions

CytoSorbDEVICE

Cytosorb device use during cardiopulmonary bypass

CytoSorb Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of \>180 minutes

You may not qualify if:

  • Platelet count \< 20,000/ uL
  • Body mass index \<18
  • Pregnant women
  • Life expectancy of \<14 days
  • End stage organ disease
  • Active infection
  • Undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (CABG) or single valve procedure
  • Contraindication to anticoagulation with heparin
  • Declined informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Kentucky

Lexington, Kentucky, United States

Location

University of Maryland

Baltimore, Maryland, United States

Location

Baystate Medical

Springfield, Massachusetts, United States

Location

Cooper University Hospital

Camden, New Jersey, United States

Location

Columbia University

New York, New York, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

Related Publications (1)

  • Heymann M, Schorer R, Putzu A. The Effect of CytoSorb on Inflammatory Markers in Critically Ill Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2023 Dec 1;51(12):1659-1673. doi: 10.1097/CCM.0000000000006007. Epub 2023 Aug 21.

    PMID: 37607074DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Joseph Zwischenberger, MD
Organization
University of Kentucky College of Medicine
jzwis2@uky.edu
859-323-6013

Study Officials

  • Steve Sisk, MSc Pharm

    CytSorbents

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 2, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

August 20, 2021

Results First Posted

August 20, 2021

Record last verified: 2021-07

Locations

US(8)