Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
- Conditions
- Venous Thromboembolism
- Registration Number
- NCT02079584
- Lead Sponsor
- Indiana University
- Brief Summary
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
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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clot Recurrence 5 years The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
Bleeding 5 years Bleeding that requires change in therapy
- Secondary Outcome Measures
Name Time Method Adherence 5 years Number of patients discontinuing anticoagulation in first 30 days and reason why
Trial Locations
- Locations (1)
Indiana University
🇺🇸Indianapolis, Indiana, United States