Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 5:33 PM
Study NCT ID:
NCT05093504
Status:
TERMINATED
Last Update Posted:
2025-05-04
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wfan@cytosorbents.com', 'phone': '1 732-329-888', 'title': 'Weihong Fan', 'organization': 'CytoSorbents'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was terminated early for business reasons, due to low enrollment. Outcome data was not cleaned, nor adjudicated. The only outcome available to analyze was the percent change in drug levels for both direct oral anticoagulants or DOACs rivaroxaban and apixaban together--there were not enough subjects to analyze DOAC levels separately.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the study duration, that is, within 30 days post-operation', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Cortisol decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Procedural anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Hypoxia', 'notes': 'Not reported as serious adverse event (SAE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Hypotension', 'notes': 'Not reported as SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Subarachnoid hemorrhage', 'notes': 'Not reported as serious adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Carotid artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Cerebral ischaemi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Post procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Perioperative Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through the first 48 hours post-operation', 'description': 'Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'classes': [{'categories': [{'measurements': [{'value': '27.95', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '62.21', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Through 30 minutes post-CPB', 'description': 'Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB', 'unitOfMeasure': 'percent change in drug levels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Chest Tube Drainage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through 24 hours post-operation', 'description': 'Drainage volume from all chest and mediastinal tubes', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Platelet Transfusions (Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total platelet transfusions (mL) during hospitalization', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Platelet Transfusions (Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total platelet transfusions (units) during hospitalization', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Packed Red Blood Cell (PRBC) Transfusions (Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total PRBC transfusions (mL) during hospitalization', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PRBC Transfusions (Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total PRBC transfusions (units) during hospitalization', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through the first day post-operation', 'description': 'Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Surgical Re-exploration for Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Incidence of Fatal Perioperative Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'OG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Deaths directly attributable to procedure-related bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'FG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-Antithrombotic Remove (ATR) system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Standard of care with Sham set-up\n\nSham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'BG001', 'title': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system\n\nDrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart failure', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary artery disease', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Subjects with apixaban', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Subjects with rivaroxaban', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 2104237, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T09:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': "Sponsor's decision for business reasons.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2021-10-01', 'resultsFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-17', 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Perioperative Bleeding', 'timeFrame': 'Through the first 48 hours post-operation', 'description': 'Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint'}], 'secondaryOutcomes': [{'measure': 'Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban', 'timeFrame': 'Through 30 minutes post-CPB', 'description': 'Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB'}, {'measure': 'Chest Tube Drainage', 'timeFrame': 'Through 24 hours post-operation', 'description': 'Drainage volume from all chest and mediastinal tubes'}, {'measure': 'Platelet Transfusions (Volume)', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total platelet transfusions (mL) during hospitalization'}, {'measure': 'Platelet Transfusions (Units)', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total platelet transfusions (units) during hospitalization'}, {'measure': 'Packed Red Blood Cell (PRBC) Transfusions (Volume)', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total PRBC transfusions (mL) during hospitalization'}, {'measure': 'PRBC Transfusions (Units)', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Total PRBC transfusions (units) during hospitalization'}, {'measure': 'Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events', 'timeFrame': 'Through the first day post-operation', 'description': 'Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)'}, {'measure': 'Surgical Re-exploration for Bleeding', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee'}, {'measure': 'Incidence of Fatal Perioperative Bleeding', 'timeFrame': 'Through to discharge from index hospitalization, on average 1-2 weeks', 'description': 'Deaths directly attributable to procedure-related bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemorrhage, Surgical', 'Hemorrhage Postoperative', 'Blood Loss, Surgical', 'Blood Loss, Postoperative']}, 'referencesModule': {'references': [{'pmid': '35657375', 'type': 'DERIVED', 'citation': 'Tripathi R, Morales J, Lee V, Gibson CM, Mack MJ, Schneider DJ, Douketis J, Sellke FW, Ohman ME, Thourani VH, Storey RF, Deliargyris EN. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery', 'detailedDescription': 'The Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants (DOACs) Apixaban \\& Rivaroxaban (STAR-D) study is a prospective, multicenter, double-blind, randomized study that evaluated the DrugSorb™-Antithrombotic Removal (ATR) device for removal of apixaban and rivaroxaban to reduce the likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery. The objectives were\n\n* To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose.\n* To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ\\[DOAC\\]) with the intraoperative use of DrugSorb-ATR.\n* To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female age 18 years or older, with documented full, written informed consent\n2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (\\*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)\n\nExclusion Criteria:\n\n1. \\>48hrs between last apixaban or rivaroxaban dose and start of CT surgery\n2. Patients on low dose apixaban or rivaroxaban for prophylactic indications\n3. Heart-lung transplant procedures\n4. Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device \\[LVAD\\] or right ventricular assist device \\[RVAD\\])\n5. Any of the below conditions that pose a known risk for increased bleeding\n\n 1. Heparin induced thrombocytopenia\n 2. Preoperative platelet count \\<50,000u/L\n 3. Hemophilia\n 4. International normalized ratio (INR) greater than or equal to 1.8\n6. Prohibited concomitant antithrombotic medications as defined in the study protocol\n7. Acute sickle cell crisis\n8. Known allergy to device components\n9. Active (untreated) systemic infection\n10. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed\n11. Women with positive pregnancy test during current admission or who are breast-feeding\n12. Life expectancy \\<30 days\n13. Inability to comply with requirements of the study protocol\n14. Treatment with investigational drug or device within 30 days of current surgery\n15. Previous enrollment in this trial'}, 'identificationModule': {'nctId': 'NCT05093504', 'acronym': 'STAR-D', 'briefTitle': 'Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytoSorbents, Inc'}, 'officialTitle': 'Safe & Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D): Prospective, Multicenter, Double-blind, Randomized Study of Apixaban & Rivaroxaban Removal to Reduce Risk of Serious Bleeding in Urgent Cardiac Surgery Patients', 'orgStudyIdInfo': {'id': '2021-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Standard of care with Sham set-up', 'interventionNames': ['Device: Sham comparator']}, {'type': 'EXPERIMENTAL', 'label': 'DrugSorb-ATR Intervention', 'description': 'Standard of care + DrugSorb-ATR system', 'interventionNames': ['Device: DrugSorb-ATR system']}], 'interventions': [{'name': 'Sham comparator', 'type': 'DEVICE', 'description': 'Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit', 'armGroupLabels': ['Control']}, {'name': 'DrugSorb-ATR system', 'type': 'DEVICE', 'otherNames': ['Sorbent hemoperfusion system'], 'description': 'Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit', 'armGroupLabels': ['DrugSorb-ATR Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown/Emory School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Saint Joseph's Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Lutheran Medical Group', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Bryan Medical Center', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Health', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '07753', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital, TriHealth, Inc', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals, Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White The Heart Hospital', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin, Inc.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Michael J Mack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Scott & White The Heart Hospital'}, {'name': 'C. M Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytoSorbents, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}