CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

CytoSorbents, Inc52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Elective Cardiac Surgery

Interventions

CytoSorbDEVICE

Cytosorb device use during cardiopulmonary bypass

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Kentucky

Lexington, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Baystate Medical

Springfield, Massachusetts, United States

Cooper University Hospital

Camden, New Jersey, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Time in the ICU

Days in ICU, Post Surgery

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

30 Day All Cause Mortality

Mortality within 30 Days of Surgery

Time frame: From time of enrollment through 30 days post procedure

Adverse Event Rates

Total number of Serious Adverse Events

Time frame: through 30 days

Data from ClinicalTrials.gov

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