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The objectives of this registry are to measure the outcomes, cost, adherence pattern and experience of patients treated as outpatients with rivaroxaban after being diagnosed with blood clots in the emergency department. The investigators hypothesize that patients will have a relatively low rate of adverse events and higher adherence than has been reported historically for warfarin treatment. Patients will be scheduled for follow up care with one of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital, Eskenazi Health Services and the Baylor University Medical Center (Dallas, TX) after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT).
Information will be obtained from the patient medical records, past medical history, physical examination at initial outpatient clinic visit 30 days (+/- 14 days) and 6 months or 180 days (+/- 14 days) post diagnosis or start of treatment, then annual follow ups for up to 5 years. The data will be collected and stored in a database, the IU RedCap database system will be used to develop a database and store information .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | A study group taken from existing anticoagulant clinics treated with warfarin. | ||
| Rivaroxaban | A group seen in the rivaroxaban clinic under study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clot Recurrence | The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin. | 5 years |
| Bleeding | Bleeding that requires change in therapy | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Number of patients discontinuing anticoagulation in first 30 days and reason why | 5 years |
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Inclusion:
Exclusion:
- If active cancer, POMPE-C <6%
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Heterogeneous group of patients pulled primarily from an emergency department population, diagnosed with low-risk VTE.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26113241 | Background | Beam DM, Kahler ZP, Kline JA. Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis. Acad Emerg Med. 2015 Jul;22(7):788-95. doi: 10.1111/acem.12711. Epub 2015 Jun 25. | |
| 26111453 | Background | Kahler ZP, Beam DM, Kline JA. Cost of Treating Venous Thromboembolism With Heparin and Warfarin Versus Home Treatment With Rivaroxaban. Acad Emerg Med. 2015 Jul;22(7):796-802. doi: 10.1111/acem.12713. Epub 2015 Jun 25. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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A blood sample will be obtained at the initial outpatient visit within 30 days (+/- 14 days) post diagnosis and/or start of treatment and at the 180 day (+/- 14 days) follow up post treatment visit and at each annual visit for up to 5 years.
| 27143861 | Result | Kline JA, Kahler ZP, Beam DM. Outpatient treatment of low-risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance. Patient Prefer Adherence. 2016 Apr 15;10:561-9. doi: 10.2147/PPA.S104446. eCollection 2016. |
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |