Trial Outcomes & Findings for Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D) (NCT NCT05093504)
NCT ID: NCT05093504
Last Updated: 2025-05-04
Results Overview
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Through the first 48 hours post-operation
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Control
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
Standard of care + DrugSorb-Antithrombotic Remove (ATR) system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
Standard of care + DrugSorb-Antithrombotic Remove (ATR) system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Baseline characteristics by cohort
| Measure |
Control
n=5 Participants
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
n=4 Participants
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Hypertension
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Heart failure
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Coronary artery disease
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Subjects with apixaban
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Subjects with rivaroxaban
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through the first 48 hours post-operationPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 30 minutes post-CPBPopulation: Because of the premature discontinuation of the study, this is the only outcome measure collected and analyzed. The change in drug levels was analyzed for both rivaroxaban and apixaban together (not separately), again due to the low number of enrolled subjects.
Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB
Outcome measures
| Measure |
Control
n=5 Participants
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
n=4 Participants
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
|---|---|---|
|
Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban
|
27.95 percent change in drug levels
Standard Deviation 8.6
|
62.21 percent change in drug levels
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Through 24 hours post-operationPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Drainage volume from all chest and mediastinal tubes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through to discharge from index hospitalization, on average 1-2 weeksPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Total platelet transfusions (mL) during hospitalization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through to discharge from index hospitalization, on average 1-2 weeksPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Total platelet transfusions (units) during hospitalization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through to discharge from index hospitalization, on average 1-2 weeksPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Total PRBC transfusions (mL) during hospitalization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through to discharge from index hospitalization, on average 1-2 weeksPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Total PRBC transfusions (units) during hospitalization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through the first day post-operationPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through to discharge from index hospitalization, on average 1-2 weeksPopulation: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.
All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through to discharge from index hospitalization, on average 1-2 weeksDeaths directly attributable to procedure-related bleeding.
Outcome measures
| Measure |
Control
n=5 Participants
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
n=4 Participants
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
|---|---|---|
|
Incidence of Fatal Perioperative Bleeding
|
0 Participants
|
0 Participants
|
Adverse Events
Control
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
DrugSorb-ATR Intervention
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control
n=5 participants at risk
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
n=4 participants at risk
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
|---|---|---|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Nervous system disorders
Cerebral ischaemi
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Cardiac disorders
Bradycardia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
Other adverse events
| Measure |
Control
n=5 participants at risk
Standard of care with Sham set-up
Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
|
DrugSorb-ATR Intervention
n=4 participants at risk
Standard of care + DrugSorb-ATR system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Infections and infestations
Clostridium difficile infection
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Infections and infestations
Urinary tract infection enterococcal
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Investigations
Blood urea increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Investigations
Cortisol decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Investigations
White blood cell count increased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Psychiatric disorders
Procedural anxiety
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Renal and urinary disorders
Azotaemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
50.0%
2/4 • Number of events 2 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Vascular disorders
Phlebitis superficial
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
0.00%
0/4 • Adverse events were collected over the study duration, that is, within 30 days post-operation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place