NCT01714297已完成4 期
A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin
Martina Hansen's Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- total blood loss
研究概览
简要总结
The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis
排除标准
- •allergy to Low-Molecular-Weight -Heparin
- •bleeding disorders
- •renal failure
- •hepatic disease
- •active treatment for malignancy
- •history of deep venous thrombosis or pulmonary embolism
- •major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.
研究组 & 干预措施
dalteparin 5000IU s.c.
Active Comparator
5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
干预措施: dalteparin 5000 IU s.c. (Drug)
saline
Placebo Comparator
Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days
干预措施: dalteparin 5000 IU s.c. (Drug)
结局指标
主要结局
total blood loss
时间窗: during and after surgery
measured blood loss during surgery and in wound drains
次要结局
- transfusion requirements(during and after surgery)
- incidence of bleeding events(during and after surgery)
- other complications(during and after surgery)
研究者
Pål Borgen, MD
MD.
Martina Hansen's Hospital
研究点 (1)
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