NCT00806533已完成不适用
Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,130
- 试验地点
- 10
- 主要终点
- incidence of adverse events
研究概览
简要总结
This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤12 years
- •Risk of anaesthesia: American Society of Anaesthesiologists (ASA) risk score: I - III
- •infusion of Venofundin 6% or of Tetraspan 6%
- •elective intervention
排除标准
- •contraindications according to SmPC
研究组 & 干预措施
HES 130 / 0.42
paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42
干预措施: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%) (Drug)
结局指标
主要结局
incidence of adverse events
时间窗: peri-operative
次要结局
未报告次要终点
研究者
研究点 (10)
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