NCT02900690终止不适用
Health Economics Evaluation of the Management of Severe Postpartum Hemorrhage: Comparison of Recombinant Activated Factor VII Strategy to the Reference Strategy
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2010年4月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- direct medical cost
研究概览
简要总结
The main objective of this project is to assess the average cost of the treatment of bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in some cases very costly invasive procedures. It will be interesting to compare the average cost of the complete strategies supported.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Severe haemorrhage is defined by the following criteria: blood loss greater than 1500 ml graduated measured in the bag and / or hemodynamically unstable and / or requiring transfusion of packed red blood cells (3);
- •Sulprostone (Nalador®) ineffective;
- •Age over 18 years;
- •The term is more than 27 SA (child's viability);
- •Without anthropomorphic limit;
- •The outcome of the pregnancy is normal or pathological;
- •Informed consent "emergency procedure" is signed by the husband or family.
排除标准
- •minors, majors in guardianship, with a personal history of venous or arterial thrombosis may cons-indicate treatment with rFVIIa or refuses to sign the consent
研究组 & 干预措施
recombinant activated factor VII (NovoSeven®)
Group using the Novoseven
Standard care
without use of the Novoseven
结局指标
主要结局
direct medical cost
时间窗: day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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