Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of blood units transfused to the patients after surgery till discharge
研究概览
简要总结
The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.
The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing heart surgery
排除标准
- 未提供
研究组 & 干预措施
Control
Traditional best-practice surgical hemostasis
干预措施: Control (Drug)
Omni-stat Celox
Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis
干预措施: Omni-stat Celox (Drug)
结局指标
主要结局
Number of blood units transfused to the patients after surgery till discharge
时间窗: 30 days
Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes
时间窗: 10 minutes
次要结局
- Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes(1,2,3,5,7,10 minutes after application)
- Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery.(3, 6, 12, 24 hours)
研究者
Luca Weltert
Project Leader Luca Weltert
Cardiochirurgia E.H.