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Sponsor's decision for business reasons.
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Standard of care with Sham set-up |
|
| DrugSorb-ATR Intervention | Experimental | Standard of care + DrugSorb-ATR system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham comparator | Device | Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Perioperative Bleeding | Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint | Through the first 48 hours post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban | Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB | Through 30 minutes post-CPB |
| Chest Tube Drainage |
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Inclusion Criteria:
Exclusion Criteria:
>48hrs between last apixaban or rivaroxaban dose and start of CT surgery
Patients on low dose apixaban or rivaroxaban for prophylactic indications
Heart-lung transplant procedures
Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device [LVAD] or right ventricular assist device [RVAD])
Any of the below conditions that pose a known risk for increased bleeding
Prohibited concomitant antithrombotic medications as defined in the study protocol
Acute sickle cell crisis
Known allergy to device components
Active (untreated) systemic infection
History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
Women with positive pregnancy test during current admission or who are breast-feeding
Life expectancy <30 days
Inability to comply with requirements of the study protocol
Treatment with investigational drug or device within 30 days of current surgery
Previous enrollment in this trial
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Mack, MD | Baylor Scott & White The Heart Hospital | Principal Investigator |
| C. M Gibson, MD | Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35657375 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | DrugSorb-ATR Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2022 |
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| DrugSorb-ATR system | Device | Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit |
|
|
Drainage volume from all chest and mediastinal tubes |
| Through 24 hours post-operation |
| Platelet Transfusions (Volume) | Total platelet transfusions (mL) during hospitalization | Through to discharge from index hospitalization, on average 1-2 weeks |
| Platelet Transfusions (Units) | Total platelet transfusions (units) during hospitalization | Through to discharge from index hospitalization, on average 1-2 weeks |
| Packed Red Blood Cell (PRBC) Transfusions (Volume) | Total PRBC transfusions (mL) during hospitalization | Through to discharge from index hospitalization, on average 1-2 weeks |
| PRBC Transfusions (Units) | Total PRBC transfusions (units) during hospitalization | Through to discharge from index hospitalization, on average 1-2 weeks |
| Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events | Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4) | Through the first day post-operation |
| Surgical Re-exploration for Bleeding | All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee | Through to discharge from index hospitalization, on average 1-2 weeks |
| Incidence of Fatal Perioperative Bleeding | Deaths directly attributable to procedure-related bleeding. | Through to discharge from index hospitalization, on average 1-2 weeks |
| Denver |
| Colorado |
| 80045 |
| United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| Advent Health | Orlando | Florida | 32803 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University Hospital Midtown/Emory School of Medicine | Atlanta | Georgia | 30308 | United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| Lutheran Medical Group | Fort Wayne | Indiana | 46804 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Mississippi | Jackson | Mississippi | 39216 | United States |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Bryan Medical Center | Lincoln | Nebraska | 68506 | United States |
| Virtua Health | Marlton | New Jersey | 08053 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Bethesda North Hospital, TriHealth, Inc | Cincinnati | Ohio | 45242 | United States |
| University Hospitals, Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor Scott & White The Heart Hospital | Plano | Texas | 75093 | United States |
| VCU Medical Center | Richmond | Virginia | 23219 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | United States |
Standard of care + DrugSorb-Antithrombotic Remove (ATR) system
DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | DrugSorb-ATR Intervention | Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Heart failure | Count of Participants | Participants |
| ||||||||||||||||
| Coronary artery disease | Count of Participants | Participants |
| ||||||||||||||||
| Subjects with apixaban | Count of Participants | Participants |
| ||||||||||||||||
| Subjects with rivaroxaban | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Perioperative Bleeding | Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint | 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. | Posted | Through the first 48 hours post-operation |
|
| ||||||||||||||||||||||
| Secondary | Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban | Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB | 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. | Posted | Mean | Standard Deviation | percent change in drug levels | Through 30 minutes post-CPB |
|
| |||||||||||||||||||
| Secondary | Chest Tube Drainage | Drainage volume from all chest and mediastinal tubes | 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. | Posted | Through 24 hours post-operation |
|
| ||||||||||||||||||||||
| Secondary | Platelet Transfusions (Volume) | Total platelet transfusions (mL) during hospitalization | 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. | Posted | Through to discharge from index hospitalization, on average 1-2 weeks |
|
| ||||||||||||||||||||||
| Secondary | Platelet Transfusions (Units) | Total platelet transfusions (units) during hospitalization | 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. | Posted | Through to discharge from index hospitalization, on average 1-2 weeks |
|
| ||||||||||||||||||||||
| Secondary | Packed Red Blood Cell (PRBC) Transfusions (Volume) | Total PRBC transfusions (mL) during hospitalization | 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. | Posted | Through to discharge from index hospitalization, on average 1-2 weeks |
|
| ||||||||||||||||||||||
| Secondary | PRBC Transfusions (Units) | Total PRBC transfusions (units) during hospitalization | 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. | Posted | Through to discharge from index hospitalization, on average 1-2 weeks |
|
| ||||||||||||||||||||||
| Secondary | Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events | Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4) | 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. | Posted | Through the first day post-operation |
|
| ||||||||||||||||||||||
| Secondary | Surgical Re-exploration for Bleeding | All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee | 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. | Posted | Through to discharge from index hospitalization, on average 1-2 weeks |
|
| ||||||||||||||||||||||
| Secondary | Incidence of Fatal Perioperative Bleeding | Deaths directly attributable to procedure-related bleeding. | Posted | Count of Participants | Participants | Through to discharge from index hospitalization, on average 1-2 weeks |
|
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Adverse events were collected over the study duration, that is, within 30 days post-operation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 5 | 1 | 5 | 2 | 5 |
| EG001 | DrugSorb-ATR Intervention | Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit | 1 | 4 | 2 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDra 24.0 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
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| Carotid artery dissection | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
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| Cerebral ischaemi | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
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| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDra 24.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 24.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDra 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDra 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDra 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDra 24.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
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| Urinary tract infection enterococcal | Infections and infestations | MedDra 24.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDra 24.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDra 24.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDra 24.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDra 24.0 | Systematic Assessment |
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| Cortisol decreased | Investigations | MedDra 24.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDra 24.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
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| Procedural anxiety | Psychiatric disorders | MedDra 24.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment | Not reported as serious adverse event (SAE) |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDra 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDra 24.0 | Systematic Assessment | Not reported as SAE |
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| Phlebitis superficial | Vascular disorders | MedDra 24.0 | Systematic Assessment |
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| Subarachnoid hemorrhage | Nervous system disorders | MedDra 24.0 | Systematic Assessment | Not reported as serious adverse event |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weihong Fan | CytoSorbents | 1 732-329-888 | wfan@cytosorbents.com |
| Apr 17, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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