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临床试验/NCT00749710
NCT00749710Unknown不适用

Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 100 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications

研究概览

简要总结

Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Delay of surgery produces less optimal results and is associated with higher morbidity even after 24-48 hours of fracture event.

Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery and related complications, as demonstrated in patients treated with Aspirin. However, cessation of antiaggregant therapy before surgery may be associated with complications of a hypercoagulable state and surgery delay.

Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin treatment in ischemic heart disease and cerebrovascular disease patients as well as in primary prevention of stent restenosis.

No data regarding complications of hip surgery in patients treated with Clpopidogrel is available.

Study hypothesis:

Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction and internal fixation of pertrochnteric and femoral neck fractures is safe although associated with more extensive blood loss during surgery and postoperative wound complications.

研究设计

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

入排标准

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

入选标准

  • age > 60
  • pertrochanteric or femoral neck fracture within 48 hours
  • clopidogrel treatment - study group
  • no antiaggregant treatment - control group
  • ASA score <=3

排除标准

  • hematologic malignancy
  • hematologic malfunction
  • warfarin treatment
  • previous active GI or other internal bleeding - within 1 year
  • thrombocytopenia < 150

结局指标

主要结局

mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

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