Elective Cardiac SurgeryREFRESHNCT02566525
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
A study testing CytoSorb in people with Elective Cardiac Surgery, run by CytoSorbents, Inc at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of >180 minutes
Who cannot join
- Platelet count < 20,000/ uL
- Body mass index <18
- Pregnant women
- Life expectancy of <14 days
- End stage organ disease
- Active infection
Show all 9Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland
Baltimore, Maryland
Cooper University Hospital
Camden, New Jersey
Baylor College of Medicine
Houston, Texas
University of Kentucky
Lexington, Kentucky
Columbia University
New York, New York
University of Pennsylvania
Philadelphia, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
Baystate Medical
Springfield, Massachusetts
About this study
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.
- Conditions
- Elective Cardiac Surgery
- Being tested
- CytoSorb
- Keywords
- CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal bypass
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Cytosorb device use during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb Device | Experimental | Standard of care plus treatment with CytSorb device installed on the CPB machine Receives: Device: CytoSorb |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)
Secondary outcomes (3)
Time in the ICU
Days in ICU, Post Surgery
Measured: 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
Measured: From time of enrollment through 30 days post procedure
Adverse Event Rates
Total number of Serious Adverse Events
Measured: through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Sisk, MSc Pharm, Study director, CytSorbents
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566525
- Sponsor's protocol ID
- 2015-001
- Acronym
- REFRESH
- Status last verified
- Jul 2021
- First submitted
- 28 Sep 2015
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heymann M, Schorer R, Putzu A. The Effect of CytoSorb on Inflammatory Markers in Critically Ill Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2023 Dec 1;51(12):1659-1673. doi: 10.1097/CCM.0000000000006007. Epub 2023 Aug 21.
PubMed 37607074
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02566525
- Acronym / sponsor ID
- REFRESH / 2015-001
- Conditions
- Elective Cardiac Surgery
- Keywords
- CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CytoSorb Device | Experimental | Device: CytoSorbStandard of care plus treatment with CytSorb device installed on the CPB machine |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of >180 minutes
Key exclusion criteria (9 listed)
- Platelet count < 20,000/ uL
- Body mass index <18
- Pregnant women
- Life expectancy of <14 days
- End stage organ disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorbCytosorb device use during cardiopulmonary bypass | Device | CytoSorb Device |
Primary outcome
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.
3 secondary outcomes
Time in the ICU
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
Time frame: From time of enrollment through 30 days post procedure
Adverse Event Rates
Time frame: through 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37607074Heymann M, Schorer R, Putzu A. The Effect of CytoSorb on Inflammatory Markers in Critically Ill Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2023 Dec 1;51(12):1659-1673. doi: 10.1097/CCM.0000000000006007. Epub 2023 Aug 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Sisk, MSc Pharm study director
CytSorbents
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb in people with Elective Cardiac Surgery, run by CytoSorbents, Inc at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Serious Device Related Adverse Events (time frame: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.