NCT01053169已完成不适用
Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 445
- 试验地点
- 6
- 主要终点
- Adequacy of stopping or preventing bleeding
研究概览
简要总结
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N
- •Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)
结局指标
主要结局
Adequacy of stopping or preventing bleeding
时间窗: Up to 24 hours after treatment
次要结局
- Vital signs(From 3 hours before and up to 24 hours after treatment)
- Clinical trigger for administration of the intervention(Up to 24 hours after treatment)
- Transfusions required(Up to 24 hours after treatment)
- International normalized ratio (INR)(From 3 hours before and up to 24 hours after treatment)
- Prothrombin time (PT)(From 3 hours before and up to 24 hours after treatment)
- Receipt of other blood products and /or hemostatic agents(Up to 24 hours after treatment)
- Mortality(Up to 24 hours after treatment)
研究者
研究点 (6)
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