NCT01134471Unknown4 期
Improvement of Hemostasis Techniques After Median Sternotomy
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Bone healing in sternum
研究概览
简要总结
The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to a control group with regards to bleeding, bone healing, pain and infection in a patient group all undergoing median sternotomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •men undergoing elective cardiac surgery at the Cardiac surgery department of Aarhus University Hospital, Skejby
- •no clopidogrel-treatment
- •no osteoporoses
- •less than 2 co-morbidities in the form of obesity (BMI>30), COPD, chronic steroid use, renal failure, immunosuppression and diabetes
排除标准
- •profuse sternal bleeding
- •serious complications to the surgery fx cerebral infarction
- •re-operation due to bleeding
结局指标
主要结局
Bone healing in sternum
时间窗: 6 months after surgery
Questionnaire regarding physical and emotional well being
时间窗: 6 months after surgery
Pain-score (VAS)
时间窗: 6 months
次要结局
- Blood product consumption(6 months)
- Mediastinitis(6 months)
- superficial infection(6 months)
- Bleeding through the chest tube(6 months)
研究者
研究点 (2)
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