Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant

Study Overview
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Brief Summary
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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).

Detailed Description
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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 .

Official Title
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Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion: DVT or PE diagnosed on imaging: Systolic always>100 mm Hg in absence of history of low blood pressure No contraindication to anticoagulation treatment (active bleeding or high risk postoperative status, creatinine clearance < 30 ml/min, history of heparin induced thrombocytopenia or warfarin skin necrosis); No other medical condition requiring hospital treatment (sepsis, new or decompensated existing organ failure, intractable pain); No social condition requiring hospital treatment (homelessness with history of non-adherence to treatment, suspected neglect or abuse, incarceration, untreated psychosis, severe alcohol or drug dependency); No coagulopathy or current anticoagulant resulting in an INR>1.7, or thrombocytopenia (platelet count < 50,000/uL); No need for supplemental oxygen (no respiratory distress and pulse ox always >94%) Exclusion: - If active cancer, POMPE-C <6%
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Warfarin<br>A study group taken from existing anticoagulant clinics treated with warfarin. | |
| Rivaroxaban<br>A group seen in the rivaroxaban clinic under study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of patients discontinuing anticoagulation in first 30 days and reason why | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Compliance, Target Specific Anticoagulant, Quality of Life