CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Not Applicable

Completed

• Conditions: Elective Cardiac Surgery
• Interventions: Device: CytoSorb

• Registration Number: NCT02566525
• Lead Sponsor: CytoSorbents, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Study Start: 2015-11
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Results First Submitted: 2019-05-20
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Results First Posted: 2021-08-20
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CytoSorb Device	CytoSorb	Standard of care plus treatment with CytSorb device installed on the CPB machine

Primary Outcome Measures

Name	Time	Method
Assessment of Serious Device Related Adverse Events	From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)	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.

Secondary Outcome Measures

Name	Time	Method
30 Day All Cause Mortality	From time of enrollment through 30 days post procedure	Mortality within 30 Days of Surgery
Adverse Event Rates	through 30 days	Total number of Serious Adverse Events
Time in the ICU	From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)	Days in ICU, Post Surgery

Trial Locations

Locations (8)

Baystate Medical; 🇺🇸 Springfield, Massachusetts, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States