NL-OMON48974尚未招募2 期
Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban. A pilot, prospective cohort study - RIVASVT100 Trial
niversità degli Studi dell'Insubria0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
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
- •1. Patients aged 18 years or older
- •2. First episode of symptomatic, objectively diagnosed PVT, MVT, or spVT
- •(diagnosed by CT, MRI and/or Doppler ultrasound).
- •3. Signed informed consent.
排除标准
- •1. Known liver cirrhosis (biopsy proven or with clinical, laboratory, or
- •imaging evidence of chronic liver disease, within a context of chronic
- •alcoholism, viral hepatitis, autoimmunity, Wilson's disease, iron overload)
- •2. Alanine aminotransferase level that is three times the upper limit of the
- •normal range or higher
- •3. Budd-Chiari syndrome
- •4. Previous or ongoing variceal bleeding
- •5. Presence of portal vein cavernoma at the time of diagnosis
- •6. Anticipated abdominal surgical procedure
- •7. Known bleeding diathesis
- •8. Platelet count <100.000 mm3
- •9. Creatinine clearance <30 mL/min (Cockroft-Gault formula)
- •10. Life expectancy of less than 3 months
- •11. Expected inability to take oral medications
- •12. Concomitant treatment with azole antimycotics and human immunodeficiency
- •virus protease inhibitors
- •13. Treatment with therapeutic doses of LMWH or UFH for more than 7 days
- •14. Ongoing treatment with Vitamin K Antagonists (VKA)
- •15. Pregnancy or lactation.
研究者
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