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Completed

NCT Number: NCT02566525

CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

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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Key information

Conditions

Elective Cardiac Surgery Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb

Device

Cytosorb device use during cardiopulmonary bypass

Primary outcomes

  1. Assessment of Serious Device Related Adverse Events

    Time frame: 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 outcomes

  1. Time in the ICU

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

    Days in ICU, Post Surgery

  2. 30 Day All Cause Mortality

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

    Mortality within 30 Days of Surgery

  3. Adverse Event Rates

    Time frame: through 30 days

    Total number of Serious Adverse Events

Other outcomes

  1. Change in Complement Factor C3a - 2 Hours Post Start of CPB

    Time frame: 2 hours post start of cardiac bypass

    Change in complement factor C3a - Sampling at 2 hours post start of CPB

  2. Change in Complement Factor C3a - 3 Hours Post Start of CPB

    Time frame: 3 hours post start of CPB

    Change in complement factor C3a - Sampling at 3 hours post start of CPB

  3. Change in Complement Factor C5a - 2 Hours Post Start of CPB

    Time frame: 2 hours post start of cardiac bypass

    Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline

Sponsors and collaborators

Lead sponsor

CytoSorbents, Inc

Industry

Registry information

Acronym: REFRESH

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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