CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (REFRESH)

CytoSorbents

Status: Completed

Conditions: Elective Cardiac Surgery

Treatments: Device: CytoSorb

Study type: Interventional

Funder types: Industry

Identifiers

NCT02566525

2015-001

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

CytoSorb Device

Experimental group

Description:

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

Treatment:

Device: CytoSorb

Control

No Intervention group

Description:

Standard of care