跳至主要内容
临床试验/NCT02900690
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

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验