CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Elective Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CytoSorb Device

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

Group Type EXPERIMENTAL

CytoSorb

Intervention Type DEVICE

Cytosorb device use during cardiopulmonary bypass

Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CytoSorb

Cytosorb device use during cardiopulmonary bypass

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No