跳至主要内容
临床试验/NCT00905229
NCT00905229撤回不适用

Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
International normalized ratio (INR) </= 1.2

研究概览

简要总结

It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment.

Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • hip fracture patients on warfarin

排除标准

  • pregnancy
  • vitamin k sensitivity

研究组 & 干预措施

PO (by mouth)

Active Comparator

2.5 mg P.O Vitamin K

干预措施: Phytonadione (Drug)

IV (intravenous )

Active Comparator

0.5 mg IV Vitamin K

干预措施: Phytonadione (Drug)

结局指标

主要结局

International normalized ratio (INR) </= 1.2

时间窗: 3 days

次要结局

  • Bleeding(6 weeks)
  • Complications(6 weeks)

研究者

申办方类型
Other

研究点 (1)

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