N/A
Completed N=46
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Elective Cardiac Surgery
Source: ClinicalTrials.gov NCT02566525 ↗
Enrolled (actual)
46
Serious AEs
58.7%
Results posted
Aug 2021
Primary outcomePrimary: Assessment of Serious Device Related Adverse Events — 2; 0; 16; 11 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Serious Device Related Adverse Events |
2; 0; 16; 11 | — |
| SECONDARY Time in the ICU |
4.34; 6.82 | — |
| SECONDARY 30 Day All Cause Mortality |
2; 1 | — |
| SECONDARY Adverse Event Rates |
44; 43 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02566525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.