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临床试验/CTIS2024-511930-11-00
CTIS2024-511930-11-00进行中(未招募)1 期

A single-center blinded crossover study investigating the efficacy of apixaban in patients with painful venous malformations with localized intravascular coagulation

Oslo University Hospital HF0 个研究点目标入组 24 人开始时间: 2024年4月25日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
24

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 65+(—)
性别
All

入选标准

  • 1.Participant must be 18–85 years of age at the time of signing the consent form, The participant must have a simple venous malformation confirmed by MRi, Localized intravascular coagulation (definition: d-dimer > 2 times upper reference area), Localized pain in venous malformation (NRS >/=4) that inhibits daily activity and/or interferes with sleep

排除标准

  • History of major bleeding, Lesion or condition if considered a significant risk factor for major bleeding., Contraindications for MRi (cochlear implant, cardiac pacemaker, intracranial clips, claustrophobia), Current treatment with platelet inhibitor (prasugrel, ticagrelor, clopidogrel, aspirin), other anticoagulation treatment e.g. unfractionated heparin, low molecular weight heparin (dalteparin, enoxaparin), heparin derivates (fondaparinux), oral anticoagulants (warfarin, dabigatran, rivaroxaban, edoxaban), NSAIDs, sirolimus, azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g., ritonavir), Under cancer therapy, Impaired kidney function (eGFR < 50 ml/min), Impaired liver function (INR > 1,3 or aminotrasferases > 3 times upper limit), Pregnancy or breast feeding, Known hypersensitivity to the active substance or to any of the excipients listed in the SmPC, Low platelet count (<100 x 10e9/mL)

研究者

发起方
Oslo University Hospital HF

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