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