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临床试验/EUCTR2014-005162-29-NL
EUCTR2014-005162-29-NL进行中(未招募)1 期

Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban. A pilot, prospective cohort study - RIVASVT100

niversity of Insubria0 个研究点目标入组 100 人开始时间: 2019年6月13日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

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.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

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 VKA
  • 15.Pregnancy or lactation.
  • Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, femalecondom, male condom). Abstinence is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if they become sexually active

研究者

发起方
niversity of Insubria

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