Trial Outcomes & Findings for CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery (NCT NCT02566525)
NCT ID: NCT02566525
Last Updated: 2021-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days)
Results posted on
2021-08-20
Participant Flow
First Patient In; 8 December, 2015 Last Patient in: 19 August 2016 Mostly university hospitals; all sites had robust cardiac surgery programs
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.
Participant milestones
| Measure |
CytoSorb Device
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
CytoSorb Device
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
5
|
Baseline Characteristics
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Baseline characteristics by cohort
| Measure |
CytoSorb Device
n=23 Participants
Standard of care plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 Participants
Standard of care
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Age, Continuous
|
66.09 Years
STANDARD_DEVIATION 7.91 • n=39 Participants
|
61.09 Years
STANDARD_DEVIATION 16.77 • n=41 Participants
|
63.59 Years
STANDARD_DEVIATION 13.21 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=39 Participants
|
23 participants
n=41 Participants
|
46 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
CytoSorb Device
n=23 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Assessment of Serious Device Related Adverse Events
Participants with at least one device related AE
|
2 participants
|
0 participants
|
|
Assessment of Serious Device Related Adverse Events
Participants with at least one SAE
|
16 participants
|
11 participants
|
SECONDARY outcome
Timeframe: From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days)Days in ICU, Post Surgery
Outcome measures
| Measure |
CytoSorb Device
n=23 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Time in the ICU
|
4.34 Days
Standard Deviation 3.34
|
6.82 Days
Standard Deviation 12.74
|
SECONDARY outcome
Timeframe: From time of enrollment through 30 days post procedurePopulation: All patients who were randomized to trial and had a surgical procedure
Mortality within 30 Days of Surgery
Outcome measures
| Measure |
CytoSorb Device
n=23 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
30 Day All Cause Mortality
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: through 30 daysPopulation: Total number of Serious Adverse Events
Total number of Serious Adverse Events
Outcome measures
| Measure |
CytoSorb Device
n=23 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Adverse Event Rates
|
44 SAE
|
43 SAE
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post start of cardiac bypassPopulation: Patients with evaluable C3a laboratories
Change in complement factor C3a - Sampling at 2 hours post start of CPB
Outcome measures
| Measure |
CytoSorb Device
n=20 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=21 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Change in Complement Factor C3a - 2 Hours Post Start of CPB
|
1146.75 ng/ml
Standard Deviation 383
|
3116.24 ng/ml
Standard Deviation 4008
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 hours post start of CPBPopulation: Patients with evaluable C3a laboratory values at 3 hours post start of CPB
Change in complement factor C3a - Sampling at 3 hours post start of CPB
Outcome measures
| Measure |
CytoSorb Device
n=15 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=10 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Change in Complement Factor C3a - 3 Hours Post Start of CPB
|
2491.1 ng/ml
Standard Deviation 1339
|
1234.67 ng/ml
Standard Deviation 424
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post start of cardiac bypassPopulation: Patients with evaluable C5a laboratories
Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline
Outcome measures
| Measure |
CytoSorb Device
n=20 Participants
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=21 Participants
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Change in Complement Factor C5a - 2 Hours Post Start of CPB
|
-7.29 ng/ml
Standard Deviation 11.9
|
0.18 ng/ml
Standard Deviation 3.98
|
Adverse Events
CytoSorb Device
Serious events: 16 serious events
Other events: 23 other events
Deaths: 2 deaths
Control
Serious events: 11 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CytoSorb Device
n=23 participants at risk
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 participants at risk
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrilation
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Atrial flutter
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Cardiac arrest
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Cardiogenic shock
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
47.8%
11/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Right ventricular dysfunction
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Bradycardia
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Cardiac perforation
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Cardiac tamponade
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Cardiopulmonary failure
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Myocardial stunning
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Pericarditis
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Pulseless electrical activity
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
13.0%
3/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Acute Lung Injury
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
Other adverse events
| Measure |
CytoSorb Device
n=23 participants at risk
Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine
CytoSorb: Cytosorb device use during cardiopulmonary bypass
|
Control
n=23 participants at risk
Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Number of events 2 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Atrial Fibrilation
|
34.8%
8/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
30.4%
7/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Cardiac disorders
Atrioventricular block first degree
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Metabolism and nutrition disorders
Fluid overload
|
21.7%
5/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
26.1%
6/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
13.0%
3/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.7%
5/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
30.4%
7/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
17.4%
4/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Blood and lymphatic system disorders
Coagulopathy
|
17.4%
4/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Blood and lymphatic system disorders
Anemia
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
4.3%
1/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
17.4%
4/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
21.7%
5/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
13.0%
3/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Atalectasis
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Vascular disorders
Hypotension
|
17.4%
4/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Vascular disorders
Haemorrhage
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Infections and infestations
Pneumonia
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Infections and infestations
Urinary tract infection
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Renal and urinary disorders
Acute kidney injury
|
21.7%
5/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
21.7%
5/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Investigations
Blood creatinine increased
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Investigations
Tranaminases increased
|
0.00%
0/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Gastrointestinal disorders
Dysphagia
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
|
Gastrointestinal disorders
Ileus
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
8.7%
2/23 • Adverse events were reported for the 30 day period following Cardiac Surgery
|
Additional Information
Dr. Joseph Zwischenberger, MD
University of Kentucky College of Medicine
Phone: 859-323-6013
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place