CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Completed · Not applicable

Conditions studied: Elective Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT02566525

Run by

CytoSorbents, Inc

People needed

52

Starts

2015-11-01

Expected to finish

2016-12-01

Last updated by the study team

2021-08-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Columbia University — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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