NL-OMON38133招募中4 期
Safety and efficiency of home treatment based on Hestia rule versus Hestia rule and NT-proBNP in patients with acute pulmonary embolism - Vesta study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- objectively proven pulmonary embolism
- •- age 18 years or older
- •- presenting to outpatient clinic or emergency ward
排除标准
- •1. Age less than 18 years
- •2. Acute onset or acute worsening of symptoms of PE (shortness of breath or chest pain without another obvious cause) lasting for more than 14 days.
- •3. Active bleeding, or a very high risk for major bleeding, i.e. gastro-intestinal bleeding in the preceding 14 days, recent stroke (less than 4 weeks ago), recent operation (less than 2 weeks ago), bleeding disorder, thrombocytopenia (platelet count < 75 x 109/L) or uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
- •4. PE accompanied by hemodynamic instability. The criteria for instability include the following: systolic blood pressure < 100 mmHg with heart rate > 100 beats per minute; possibly in combination with one or more of the following symptoms of organ perfusion defects: oliguria, pale skin or elevated lactate levels in arterial blood gas analysis, altered mental state, or any other PE related condition requiring admission to an intensive care unit.
- •5. Acute PE requiring thrombolytic treatment or pulmonary embolectomy
- •6. Requirement for oxygen therapy to maintain oxygen saturation greater than 90%
- •7. Severe pain requiring intravenous narcotic analgesia
- •8. Medical or social condition which necessitates admission to the hospital for another reason (for example infection, cancer or stroke) without discharge in the next 24hours
- •9. Diagnosis of PE during anticoagulant treatment (profylatic dosis of LMWH is allowed)
- •10. Severe renal failure e.g. calculated creatinine clearance < 30 ml/min. Cockcroft-Gault formula or MDRD is acceptable.
- •11. Pregnancy
- •12. Previously documented heparin induced thrombocytopenia
- •13. Severe liver failure (according judgement of physician)
- •14. Likelihood of non-compliance (e.g. no fixed address)
- •15. Life expectancy less than three months
- •16. Participation in this study during a previous episode of acute PE.
- •17. Participation in another therapeutic trial (diagnostic studies are allowed)
- •18. Failure to sign informed consent.
研究者
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