Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Clot Recurrence
研究概览
简要总结
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).
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clot Recurrence
时间窗: 5 years
The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
Bleeding
时间窗: 5 years
Bleeding that requires change in therapy
次要结局
- Adherence(5 years)