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| Name | Class |
|---|---|
| CardioMed Device Consultants, LLC | INDUSTRY |
| Intrinsic Imaging, LLC | UNKNOWN |
| Novella Clinical | OTHER |
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The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Angel® Catheter | Experimental | All eligible subjects will receive an Angel® Catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Angel® Catheter | Device | The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Clinically Significant PE or Fatal PE During Treatment Period |
| Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Proximal Deep Vein Thrombosis | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) | |
| Incidence of Catheter Related Thrombosis |
Not provided
Inclusion Criteria:
Subject or legally authorized representative is willing and able to provide written informed consent,
Subject is 18 years or older,
Subject is expected to remain in a critical care setting for at least 72 hours,
AND at least one of the following inclusion criteria (4,5, and/or 6)
Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:
Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
Subject requires a temporary interruption (>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Tapson, MD | Cedars Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| UC San Diego Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Angel® Catheter | All eligible subjects will receive an Angel® Catheter. The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
|
| Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
| Incidence of Catheter Related Blood Stream Infections | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
| Incidence of Major Bleeding Event | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
| Incidence of PEs Averted | During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted. | During the pre-removal cavogram (An average of 6.8 days after device insertion) |
| San Diego |
| California |
| 92103 |
| United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Delray Medical Center | Delray Beach | Florida | 33483 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| UF Health Shands Cancer Hospital | Gainesville | Florida | 32608 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| St. Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| University of New Mexico Health | Albuquerque | New Mexico | 87106 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Regional One Health | Memphis | Tennessee | 38103 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| John Peter Smith Health Network | Fort Worth | Texas | 76104 | United States |
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
|
| Device Placed |
|
| COMPLETED | (i.e., Device in place for at least 48 hours) |
|
| NOT COMPLETED |
|
|
Population includes all subjects that had the Angel® Catheter placed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | The Angel® Catheter | All eligible subjects received an Angel® Catheter. The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Customized | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Time from admission to the hospital to admission to ICU | Mean | Standard Deviation | hours |
| |||||||||||||||||
| Time from admission to the hospital to admission to ICU | Median | Full Range | hours |
| |||||||||||||||||
| Primary ICU Admission Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||
| Type of trauma (for trauma subjects) | Number analyzed includes all trauma subjects that had an Angel® Catheter placed | Count of Participants | Participants |
| |||||||||||||||||
| Injury Severity Score (for trauma subjects) | Injury Severity Score (ISS) Scale: Minimal (1-9); Moderate (10-15); Severe (16-24); Critical (25+); Trauma subjects categorized by their ISS, with higher scores representing more serious/life-threating injuries. This anatomical scoring system providing an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score and allocated to 1/6 body regions (Head, Face, Chest, Abdomen, Extremities & Pelvis, External). Highest score in each body region is used. 3 most severely injured regions have score squared and added to produce the ISS score. | Measure Analysis is specific only to trauma subjects. | Mean | Standard Deviation | Injury Severity Score |
| |||||||||||||||
| Injury Severity Score (for trauma subjects) | Number analyzed includes all trauma subjects that had an Angel® Catheter placed | Median | Full Range | Injury Severity Score |
| ||||||||||||||||
| Injury Classification | Trauma subjects were categorized based on their Injury Severity Score (ISS), with higher scores representing more serious or life-threating injuries. The ISS is an anatomical scoring system that provides an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score and allocated to one of six body regions (Head, Face, Chest, Abdomen, Extremities (including Pelvis), External). The highest AIS score in each body region is used. The 3 most severely injured body regions have their score squared and added together to produce the ISS score. | Number analyzed includes all trauma subjects that had the Angel® Catheter placed. | Count of Participants | Participants |
| ||||||||||||||||
| Bleeding Risk | Count of Participants | Participants |
| ||||||||||||||||||
| Severity of Active Bleeding | Number analyzed includes all subjects with active bleeding at enrollment and subsequently had an Angel® Catheter placed. | Count of Participants | Participants |
| |||||||||||||||||
| Medical History & Concomitant Conditions | Count of Participants | Participants |
| ||||||||||||||||||
| Subjects with Baseline Venous Thromboembolic (VTE) Disease per Site-reported Medical History | Count of Participants | Participants |
| ||||||||||||||||||
| Use of mechanical DVT preventive devices | Count of Participants | Participants |
| ||||||||||||||||||
| Supplemental Oxygen at Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Type of supplemental oxygen | Number analyzed includes all patient receiving supplemental oxygen at enrollment that subsequently had an Angel® Catheter placed. | Count of Participants | Participants |
| |||||||||||||||||
| Need for vasopressors before Angel® Catheter insertion | Count of Participants | Participants |
| ||||||||||||||||||
| Other Central Venous Catheter (CVC) in place prior to Angel® Catheter insertion | Count of Participants | Participants |
| ||||||||||||||||||
| Indications for the Angel® Catheter Placement | Count of Participants | Participants |
| ||||||||||||||||||
| Contraindications to anticoagulation | Number analyzed includes all subjects that had recognized contraindications to standard pharmacological thromboprophylaxis reported. | Count of Participants | Participants |
|
| 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 | Freedom From Clinically Significant PE or Fatal PE During Treatment Period |
| Posted | Count of Participants | Participants | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days) |
|
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Acute Proximal Deep Vein Thrombosis | Posted | Count of Participants | Participants | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Catheter Related Thrombosis | Posted | Count of Participants | Participants | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Catheter Related Blood Stream Infections | Posted | Count of Participants | Participants | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Major Bleeding Event | Posted | Count of Participants | Participants | Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of PEs Averted | During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted. | Posted | Count of Participants | Participants | During the pre-removal cavogram (An average of 6.8 days after device insertion) |
|
|
From the time of Angel® Catheter insertion, through the entire catheter indwelling period (Mean±SD: 6.79±3.97 days; Median(Range: Min,Max): 5.94 (0.34,21.92) days), until death, discharge or 3 days post-removal, whichever occurs first.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Angel® Catheter | All eligible subjects received an Angel® Catheter. The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein. | 49 | 163 | 114 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Supraventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Brain Death | General disorders | Non-systematic Assessment |
| ||
| Multi-Organ Failure | General disorders | Non-systematic Assessment |
| ||
| Chronic Hepatic Failure | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Abdominal Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Lobar Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Non-systematic Assessment |
| ||
| Craniocerebral Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Subdural Haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Subdural Haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Brain Hypoxia | Nervous system disorders | Non-systematic Assessment |
| ||
| Brain Oedema | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Haemorrhage Intracranial | Nervous system disorders | Non-systematic Assessment |
| ||
| Intracranial Pressure Increased | Nervous system disorders | Non-systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal Failure Acute | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Haemodynamic Instability | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Pelvic Venous Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Vena Cava Thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal wall haematoma | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Accelerated hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Acinetobacter infection | Infections and infestations | Non-systematic Assessment |
| ||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anastomotic leak | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anxiety disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Autonomic nervous system imbalance | Nervous system disorders | Non-systematic Assessment |
| ||
| Axillary vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Non-systematic Assessment |
| ||
| Bacterial vaginosis | Infections and infestations | Non-systematic Assessment |
| ||
| Blood albumin decreased | Investigations | Non-systematic Assessment |
| ||
| Body temperature increased | Investigations | Non-systematic Assessment |
| ||
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Catheter site haemorrhage | General disorders | Non-systematic Assessment |
| ||
| Central nervous system infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cerebral hypoperfusion | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Non-systematic Assessment |
| ||
| Clostridium test positive | Investigations | Non-systematic Assessment |
| ||
| Compartment syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Culture urine positive | Investigations | Non-systematic Assessment |
| ||
| Cyanosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Device damage | General disorders | Non-systematic Assessment |
| ||
| Device deployment issue | General disorders | Non-systematic Assessment |
| ||
| Device dislocation | General disorders | Non-systematic Assessment |
| ||
| Diabetes insipidus | Endocrine disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diffuse axonal injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Escherichia urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Femoral artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Gastric hypomotility | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal bacterial infection | Infections and infestations | Non-systematic Assessment |
| ||
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Glucose tolerance impaired | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Haemorrhagic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Haemothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hyercapnia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypernatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hyperthermia | General disorders | Non-systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypoxia | Vascular disorders | Non-systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Intracranial pressure increased | Nervous system disorders | Non-systematic Assessment |
| ||
| Klebsiella test positive | Investigations | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Lobar pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Local swelling | General disorders | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Melaena | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Meningitis bacterial | Infections and infestations | Non-systematic Assessment |
| ||
| Mental impairment | Nervous system disorders | Non-systematic Assessment |
| ||
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle necrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myoglobinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Neurological symptom | Nervous system disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Oral disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pelvic venous thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Peritonitis | Infections and infestations | Non-systematic Assessment |
| ||
| Platelet count increased | Vascular disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia klebsiella | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia pneumococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia psudomonal | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia staphylococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Postoperative wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Post-traumatic stress disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulse absent | Investigations | Non-systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Scleral oedema | Eye disorders | Non-systematic Assessment |
| ||
| Secondary hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Non-systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Subclavian vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombophlebitis superficial | Vascular disorders | Non-systematic Assessment |
| ||
| Tracheobronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Unintentional medical device removal | General disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vena cava thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Non-systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Wound infection pseudomonas | Infections and infestations | Non-systematic Assessment |
| ||
| Wound sepsis | Infections and infestations | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Bio2 Medical, Inc. | 720-833-5675 | langel@bio2medical.com |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| D014947 | Wounds and Injuries |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D013923 | Thromboembolism |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
|
| Unknown or Not Reported |
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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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| Medical |
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| Neurological |
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| Chest |
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| Abdomen |
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| Lower Extremity Trauma |
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| More than one area affected |
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| Head Bleed (Subcategory of Head/Spinal Trauma) |
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| Moderate (10-15) |
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| Severe (16-24) |
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| Critical (25+) |
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| At high risk for bleeding |
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| Major bleeding |
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| Endocrine disorders |
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| Ear and labyrinth disorders |
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| Eye disorders |
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| Gastrointestinal disorders |
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| General disorders and administration site conditio |
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| Hepatobiliary disorders |
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| Immune system disorders |
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| Infections and infestations |
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| Injury, poisoning, and procedural complications |
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| Investigations |
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| Metabolism and nutrition disorders |
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| Musculoskeletal and connective tissue disorders |
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| Neoplasms benign, malignant, and unspecified |
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| Nervous system disorders |
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| Psychiatric disorders |
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| Renal and urinary disorders |
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| Reproductive system and breast disorders |
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| Respiratory, thoracic and mediastinal disorders |
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| Skin and subcutaneous tissue disorders |
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| Social circumstances |
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| Surgical and medical procedures |
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| Vascular disorders |
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| Deep Vein Thrombosis (DVT) |
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| PE and DVT |
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| Pneumatic compression |
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| Other |
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| CPAP-BiPAP |
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| Nasal cannula/face mask |
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| Other |
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| Long term CVC |
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| Acute LE DVT or PE & contraindicated to anticoagul |
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| Temporary interruption of anticoagulation |
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| Prophylactic Use of Indications for the Angel® Cat |
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| Hypersensitivity to anticoagulation |
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| History of severe heparin induced thrombocytopenia |
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| Severe thrombocytopenia |
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| Other |
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