DRKS00000697已完成未知
COSTA - Closure of median sternotomy in high-risk patients with the sternal talon system - COSTA
Gebrüder Martin GmbH & Co. KG0 个研究点目标入组 338 人开始时间: 2011年1月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •planned median sternotomy
- •- at least 18 years old
- •- at least 4 of the following risk factors:
- •age at least 65 years
- •age at least 80 years
- •myocardial infarction within the last 90 days and left-ventricular ejection fraction at or below 35%
- •peripheral arterial disease
- •chronic obstructive pulmonary disease
- •creatinine at or above 200 µmol
- •immunosuppression, cytostatics
- •critical general condition
- •planned utilization of both Aa. mammariae
- •body mass index at or above 30 kg/m²
- •body mass index at or above 40 kg/m²
排除标准
- •- hyperresponsiveness to titanium
- •- systemic antibiotic therapy
- •- thoracic anomaly
- •- pregnancy possible, breast-feeding
- •- lacking compliance
研究者
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