Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
研究概览
简要总结
The aim of this study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE) in the outpatient group will be studied.
详细描述
Pulmonary embolism is a major health problem. Because of risk for early hemodynamic instability and mortality, all patients with a recently diagnosed pulmonary embolism are treated in hospital. The clinical course of most patients is without complications. In practice most of the patients are only waiting in hospital in a good, clinical stable condition until their INR range is stable.
This prospective management study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels (< 500 pg/ml). The incidence of complications due to the pulmonary embolism or its treatment will be followed during the first ten days of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatient with a pulmonary embolism, confirmed by locally approved guidelines
- •aged 18 years and above
- •written informed consent
排除标准
- •hemodynamic or respiratory instability defined as one of the following; hypotension RR systolic< 90 mmHg,pulse rate> 100 bpm, need for oxygen therapy to maintain oxygen saturation above 90 %, collapse
- •illness unrelated to PE for which the patient would require hospitalization
- •pain requiring intravenous narcotics
- •thrombolysis
- •active bleeding or thrombopathy
- •pregnancy
- •in hospital patients
- •physical or psychiatric inability for home treatment
- •no support system at home renal insufficiency
结局指标
主要结局
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
次要结局
- Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism