CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Elective Cardiac Surgery Clinical Trial

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Official title:

CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566525
• Other study ID #: 2015-001
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2021
• Source: CytoSorbents, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Elective Cardiac Surgery

Intervention

Device:
• CytoSorb
Cytosorb device use during cardiopulmonary bypass

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Cooper University Hospital	Camden	New Jersey
United States	Baylor College of Medicine	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baystate Medical	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Complement Factor C3a - 2 Hours Post Start of CPB	Change in complement factor C3a - Sampling at 2 hours post start of CPB	2 hours post start of cardiac bypass
Other	Change in Complement Factor C3a - 3 Hours Post Start of CPB	Change in complement factor C3a - Sampling at 3 hours post start of CPB	3 hours post start of CPB
Other	Change in Complement Factor C5a - 2 Hours Post Start of CPB	Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline	2 hours post start of cardiac bypass
Primary	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	Time in the ICU	Days in ICU, Post Surgery	From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)
Secondary	30 Day All Cause Mortality	Mortality within 30 Days of Surgery	From time of enrollment through 30 days post procedure
Secondary	Adverse Event Rates	Total number of Serious Adverse Events	through 30 days