Trial Outcomes & Findings for Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (NCT NCT04976530)

Last Updated: 2025-04-11

Results Overview

Incidence of periop bleeding, primary effectiveness composite endpoint, mITT population. Primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins \> 1.0 favors the treatment arm. 95% confidence interval (CI) and p-value are calculated accordingly. The win ratio is 1.07 (95% CI 0.72, 1.58), p=0.748.

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

Through the first 48hrs post-operation

Results posted on

2025-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Control Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Overall Study STARTED	70	70
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=66 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 Participants Standard of care + DrugSorb-ATR system DrugSorb-Antithrombotic Removal (ATR) system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit	Total n=132 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 8.54 • n=5 Participants	64.4 years STANDARD_DEVIATION 10.63 • n=7 Participants	64.5 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	56 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Canada	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	43 participants n=7 Participants	87 participants n=5 Participants
Hypertension	58 Participants n=5 Participants	54 Participants n=7 Participants	112 Participants n=5 Participants
Heart failure	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Coronary artery disease	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants
Thrombocytopenia	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through the first 48hrs post-operation

Population: mITT, modified intent-to-treat

Outcome measures

Outcome measures
Measure	Control n=66 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population	2103 number of wins	2244 number of wins

PRIMARY outcome

Timeframe: Through the first 48hrs post operation

Population: i-CABG, isolated CABG, per protocol population

Incidence of periop bleeding, primary effectiveness composite endpoint, i--CABG population. The primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in the Sham arm. A ratio of wins \>1.0 favors the treatment arm. The win ratio was 1.33 (95% confidence interval 0.86, 2.04) p-value 0.202.

Outcome measures

Outcome measures
Measure	Control n=60 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=51 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Isolated Coronary Artery Bypass Grafting (I-CABG) Per Protocol (PP) Population	1310 number of wins	1741 number of wins

PRIMARY outcome

Timeframe: Through the first 48 hours post-operation

Population: mITT, modified intent-to-treat

Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers given below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins \>1.0 favors the treatment arm. The win ratio was 1.17 (95% confidence interval 0.79, 1.73) p value 0.451.

Outcome measures

Outcome measures
Measure	Control n=66 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population	2005 number of wins	2336 number of wins

PRIMARY outcome

Timeframe: Through the first 48hrs post-operation

Population: i-CABG PP: subjects undergoing isolated CABG procedures, per protocol (those without major protocol deviations that would affect determination of device effectiveness.

Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) \>3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins \>1.0 favors the treatment arm. The win ratio was 1.59 (95% confidence interval 1.02, 2.46) p-value 0.041.

Outcome measures

Outcome measures
Measure	Control n=60 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=51 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG Per Protocol (PP) Population	1178 number of wins	1868 number of wins

SECONDARY outcome

Timeframe: Through 24hrs post-operation

Population: mITT (all enrolled subjects who received a study device)

Drainage volume from all chest and mediastinal tubes

Outcome measures

Outcome measures
Measure	Control n=66 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Chest Tube Drainage, mITT Population	746 mL Interval 200.0 to 2670.0	715 mL Interval 205.0 to 8956.0

SECONDARY outcome

Timeframe: Through 24hrs post-operation

Population: isolated CABG per protocol population

Drainage volume from all chest and mediastinal tubes

Outcome measures

Outcome measures
Measure	Control n=60 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=51 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Chest Tube Drainage, i-CABG PP Population	765 mL Interval 200.0 to 2670.0	645 mL Interval 205.0 to 3425.0

SECONDARY outcome

Timeframe: Through 12hrs post-operation

Population: mITT (all enrolled subjects who received a study device)

Drainage volume from all chest and mediastinal tubes

Outcome measures

Outcome measures
Measure	Control n=66 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Chest Tube Drainage, mITT Population	487 mL Interval 140.0 to 1690.0	430 mL Interval 35.0 to 8050.0

SECONDARY outcome

Timeframe: Through 12hrs post-operation

Population: isolated CABG per protocol population

Drainage volume from all chest and mediastinal tubes

Outcome measures

Outcome measures
Measure	Control n=60 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=51 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Chest Tube Drainage, i-CABG PP Population	487 mL Interval 165.0 to 1690.0	410 mL Interval 35.0 to 1480.0

SECONDARY outcome

Timeframe: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

Population: mITT

Total PRBC transfusions (units) during hospitalization in the mITT population

Outcome measures

Outcome measures
Measure	Control n=35 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=40 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population	3 PBRC Units Interval 1.0 to 10.0	2.5 PBRC Units Interval 1.0 to 25.0

SECONDARY outcome

Timeframe: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

Population: I-CABG PP, isolated CABG per protocol population

Total PRBC transfusions (units) during hospitalization

Outcome measures

Outcome measures
Measure	Control n=30 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=27 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
PRBC Transfusions, (Units) I-CABG PP Population	3 PRBC units Interval 1.0 to 10.0	2 PRBC units Interval 1.0 to 20.0

SECONDARY outcome

Timeframe: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

Population: mITT

Total Platelet transfusions (units) during hospitalization

Outcome measures

Outcome measures
Measure	Control n=27 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=31 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Platelet Transfusions (Units), mITT Population	2 PBRC units Interval 1.0 to 5.0	2 PBRC units Interval 1.0 to 10.0

SECONDARY outcome

Timeframe: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

Population: I-CABG PP, isolated CABG per protocol population

Total Platelet transfusions (units) during hospitalization

Outcome measures

Outcome measures
Measure	Control n=24 Participants Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=21 Participants Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Platelet Transfusions, (Units), I-CABG PP Population	2 Platelet units Interval 1.0 to 5.0	2 Platelet units Interval 1.0 to 8.0

Adverse Events

Control

Serious events: 19 serious events

Other events: 57 other events

Deaths: 1 deaths

DrugSorb-ATR Intervention

Serious events: 25 serious events

Other events: 58 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Weihong Fan

CytoSorbents Corp

Phone: 732-329-8885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Control n=66 participants at risk Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 participants at risk Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Product Issues Device breakage	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Psychiatric disorders Mental status changes	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Atrial fibrillation	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Cardiac tamponade	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Cardiogenic shock	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Atrial flutter	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Cardiac arrest	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Cardiac failure	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Cardiac failure acute	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Pericardial effusion	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Right ventricular failure	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Supraventricular tachycardia	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Ventricular arrhythmia	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Ventricular dysfunction	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Ventricular tachycardia	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Anaemia	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Blood loss anaemia	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Hypotension	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Haemorrhage	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Hypertension	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Shock haemorrhage	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Procedural haemorrhage	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Vasoplegia syndrome	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Post-procedural haemorrhage	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Postoperative respiratory failure	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Vascular graft occlusion	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Wound dehiscence	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Nervous system disorders Cerebral vascular event	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Nervous system disorders Lacunar infarction	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Nervous system disorders Neuropathy peripheral	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Nervous system disorders Syncope	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).

Other adverse events
Measure	Control n=66 participants at risk Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit	DrugSorb-ATR Intervention n=66 participants at risk Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Cardiac disorders Atrial fibrillation	33.3% 22/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	42.4% 28/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Cardiac disorders Pericarditis	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Haemothorax	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Pleural effusion	19.7% 13/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	24.2% 16/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Atelectasis	12.1% 8/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	12.1% 8/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Pneumothorax	12.1% 8/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Anaemia	16.7% 11/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	16.7% 11/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Leukocytosis	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	10.6% 7/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Blood loss anaemia	12.1% 8/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	10.6% 7/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Blood and lymphatic system disorders Thrombocytopenia	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	12.1% 8/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Hypotension	9.1% 6/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	13.6% 9/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Investigations	15.2% 10/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	18.2% 12/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Blood albumin decreased	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Vascular disorders Protein total decreased	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Procedural pain	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Vasoplegia syndrome	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Injury, poisoning and procedural complications Anemia postoperative	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Renal and urinary disorders Acute kidney injury	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	18.2% 12/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Renal and urinary disorders General disorders and administration site conditions	12.1% 8/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	15.2% 10/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Renal and urinary disorders Oedema peripheral	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Metabolism and nutrition disorders Hyperglycaemia	13.6% 9/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Metabolism and nutrition disorders Hypocalcaemia	4.5% 3/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Metabolism and nutrition disorders Hypervolaemia	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Metabolism and nutrition disorders Hypoalbuminaemia	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Metabolism and nutrition disorders Hyponatraemia	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	1.5% 1/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Gastrointestinal disorders Gastrointestinal disorders	10.6% 7/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	13.6% 9/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Gastrointestinal disorders Constipation	6.1% 4/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Psychiatric disorders Psychiatric disorders	3.0% 2/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	10.6% 7/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).
Psychiatric disorders Delirium	0.00% 0/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).	7.6% 5/66 • 30 days The primary safety endpoint of this study was to evaluate the product safety profile through the Good Clinical Practice level assessment of adverse events (AEs) during the study period. This study evaluated a device, therefore, in this section we report all Device-related serious adverse events (SAEs).