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Due to slow enrollment.
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Part 1 - Evaluate the real-world implementation of extended prophylaxis with betrixaban in the acutely ill hospitalized medical population Part 2 - Describe patterns of Venous thromboembolism (VTE) prophylaxis in acutely ill medical patients who qualify for extended VTE prophylaxis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Patients at risk of VTE who are prescribed betrixaban to prevent VTE | ||
| Cohort 2 | Patients at risk of VTE who are prescribed betrixaban or other VTE prophylaxis |
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| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic Events at 45 days: VTE, MI, Stroke, Transient ischemic attack (TIA) | Thrombotic Events at 45 days: VTE, MI, Stroke, TIA | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding rates at 45 days | Bleeding rates at 45 days | 45 days |
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Inclusion Criteria:
-Part 1 -
Part 2 -
Hospitalized acutely ill medical patient
Patient prescribed betrixaban OR must satisfy criteria a and b:
Age > 70 years D-dimer > 2x institutional Upper Limit of Normal (ULN) Obesity: Body mass index (BMI) > 30 kg/m2) History of pulmonary embolism (PE) or deep venous thrombosis (DVT) Active cancer (diagnosed, treated, or progressing in the past 6 months) History of thrombophilia Recent trauma or surgery (within 30 days prior to admission) Ongoing hormonal treatment ICU stay 3. Signed informed consent
Exclusion Criteria:
Part 1 - 1. High bleeding risk - any of the following:
Part 2
Patients who are on another oral anticoagulant (OAC) for any reason at the time of hospitalization and will remain on it
Condition requiring use of OAC at admission, other than VTE prophylaxis (eg, acute VTE at admission)
High bleeding risk any of the following:
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Acutely ill medical patients, hospitalized, prescribed therapy for VTE prophylaxis and who would qualify for extended prophylaxis (whether or not they receive prophylaxis).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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