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临床试验/NCT05874674
NCT05874674招募中不适用

The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Diathesis Undergoing Hemodialysis: A Pilot Study

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Number of patients with severe bleeding

研究概览

简要总结

Comparison nafamostat and low molecular weight heparin among dialysis patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • platelet below 10k PTT above 60 second INR above 20 patient with bleeding (epistaxis, orbital bleeding, hematuria) recent brain hemorrhage (within 6 months) receiving anticoagulant therapy (coumadin or NOAC) dual antiplatelet agent users received major surgery within one month

排除标准

  • cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)

研究组 & 干预措施

nafamostat

Active Comparator

Patients received dialysis through nafamostat

干预措施: Nafamostat Mesylate (Drug)

结局指标

主要结局

Number of patients with severe bleeding

时间窗: 6 month

Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)

次要结局

  • Number of patients with dialysis circuit clot(6 month)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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