NCT01354704已完成4 期
Echo-Doppler Assessment of the Occurrence of Asymptomatic Deep Vein Thrombosis (DVT) in Orthopedic Replacement Surgery Under Enoxaparine (PRENOXA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Presence or absence of ultrasound findings in favor of asymptomatic DVT
研究概览
简要总结
The objectives of the study are:
o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA
o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these patients compared with the original drug Lovenox ®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •man or woman aged over 18 years, admitted to undergo orthopedic total knee or total hip prosthesis requiring the use of enoxaparin 4000 IU for the Prophylaxis.
排除标准
- •Patient participating in another study.
- •hypersensitivity to enoxaparin sodium, heparin unfractionated heparin or other low molecular weight.
- •Patients at risk of major bleeding or uncontrolled including patients with recent stroke
研究组 & 干预措施
lovenox
Active Comparator
patient under lovenox 4000 IU
干预措施: Enoxaparin (Drug)
enoxa
Active Comparator
patients under Enoxa 4000 IU
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Presence or absence of ultrasound findings in favor of asymptomatic DVT
时间窗: Day 7 and 35
After orthopedic surgery, patients are put under LMWH thromboprophylaxis based but some patients may be carrying an asymptomatic DVT. so we'll try the distal venous thrombosis rate in these patients using Doppler ultrasound.
次要结局
- To evaluate the efficacy and tolerability clinical Enox ® in these patients.(3 months)
研究者
研究点 (1)
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