Elective Cardiac Surgery
Conditions
Keywords
CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal bypass
Brief 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.
Interventions
DEVICECytoSorb
Cytosorb device use during cardiopulmonary bypass
Sponsors
CytoSorbents, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Serious Device Related Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Time in the ICU | From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) | Days in ICU, Post Surgery |
| 30 Day All Cause Mortality | From time of enrollment through 30 days post procedure | Mortality within 30 Days of Surgery |
| Adverse Event Rates | through 30 days | Total number of Serious Adverse Events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Complement Factor C3a - 3 Hours Post Start of CPB | 3 hours post start of CPB | Change in complement factor C3a - Sampling at 3 hours post start of CPB |
| Change in Complement Factor C5a - 2 Hours Post Start of CPB | 2 hours post start of cardiac bypass | Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline |
| Change in Complement Factor C3a - 2 Hours Post Start of CPB | 2 hours post start of cardiac bypass | Change in complement factor C3a - Sampling at 2 hours post start of CPB |
Countries
United States
Participant flow
Recruitment details
First Patient In; 8 December, 2015 Last Patient in: 19 August 2016 Mostly university hospitals; all sites had robust cardiac surgery programs
Pre-assignment details
Potential patients had to have a planned 3+ hour bypass time. Isolated coronary bypass graft or single valve procedures were excluded. Cases included were aortic reconstructions, valve repairs, valve replacements and combinations thereof, and permitted combination with coronary bypass graft. Emergency and endocarditis patients were excluded. 52 patients enrolled in the study, of which 6 withdrew from the study.
Participants by arm
| Arm | Count |
|---|---|
| CytoSorb Device Standard of care plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass | 23 |
| Control Standard of care | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 5 |
Baseline characteristics
| Characteristic | Control | CytoSorb Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 61.09 Years STANDARD_DEVIATION 16.77 | 66.09 Years STANDARD_DEVIATION 7.91 | 63.59 Years STANDARD_DEVIATION 13.21 |
| Region of Enrollment United States | 23 participants | 23 participants | 46 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 18 Participants | 13 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 23 | 1 / 23 |
| other Total, other adverse events | 23 / 23 | 21 / 23 |
| serious Total, serious adverse events | 16 / 23 | 11 / 23 |
Outcome results
Primary
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.
Time frame: From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)
Population: All patients who had at least on Adverse Event
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CytoSorb Device | Assessment of Serious Device Related Adverse Events | Participants with at least one device related AE | 2 participants |
| CytoSorb Device | Assessment of Serious Device Related Adverse Events | Participants with at least one SAE | 16 participants |
| Control | Assessment of Serious Device Related Adverse Events | Participants with at least one device related AE | 0 participants |
| Control | Assessment of Serious Device Related Adverse Events | Participants with at least one SAE | 11 participants |
Secondary
30 Day All Cause Mortality
Mortality within 30 Days of Surgery
Time frame: From time of enrollment through 30 days post procedure
Population: All patients who were randomized to trial and had a surgical procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CytoSorb Device | 30 Day All Cause Mortality | 2 participants |
| Control | 30 Day All Cause Mortality | 1 participants |
Secondary
Adverse Event Rates
Total number of Serious Adverse Events
Time frame: through 30 days
Population: Total number of Serious Adverse Events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CytoSorb Device | Adverse Event Rates | 44 SAE |
| Control | Adverse Event Rates | 43 SAE |
Secondary
Time in the ICU
Days in ICU, Post Surgery
Time frame: From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytoSorb Device | Time in the ICU | 4.34 Days | Standard Deviation 3.34 |
| Control | Time in the ICU | 6.82 Days | Standard Deviation 12.74 |
Other Pre-specified
Change in Complement Factor C3a - 2 Hours Post Start of CPB
Change in complement factor C3a - Sampling at 2 hours post start of CPB
Time frame: 2 hours post start of cardiac bypass
Population: Patients with evaluable C3a laboratories
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytoSorb Device | Change in Complement Factor C3a - 2 Hours Post Start of CPB | 1146.75 ng/ml | Standard Deviation 383 |
| Control | Change in Complement Factor C3a - 2 Hours Post Start of CPB | 3116.24 ng/ml | Standard Deviation 4008 |
Other Pre-specified
Change in Complement Factor C3a - 3 Hours Post Start of CPB
Change in complement factor C3a - Sampling at 3 hours post start of CPB
Time frame: 3 hours post start of CPB
Population: Patients with evaluable C3a laboratory values at 3 hours post start of CPB
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytoSorb Device | Change in Complement Factor C3a - 3 Hours Post Start of CPB | 2491.1 ng/ml | Standard Deviation 1339 |
| Control | Change in Complement Factor C3a - 3 Hours Post Start of CPB | 1234.67 ng/ml | Standard Deviation 424 |
Other Pre-specified
Change in Complement Factor C5a - 2 Hours Post Start of CPB
Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline
Time frame: 2 hours post start of cardiac bypass
Population: Patients with evaluable C5a laboratories
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytoSorb Device | Change in Complement Factor C5a - 2 Hours Post Start of CPB | -7.29 ng/ml | Standard Deviation 11.9 |
| Control | Change in Complement Factor C5a - 2 Hours Post Start of CPB | 0.18 ng/ml | Standard Deviation 3.98 |