Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA
研究概览
简要总结
the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Regardless of age
- •No inhibitor (anti-FVIII alloantibodies) at the time of treatment.
- •No objections expressed to participate in the study after having been informed of its purposes and the data involved.
- •No other inherited hemorrhagic disorders than HA
排除标准
- •In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.
结局指标
主要结局
Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA
时间窗: 1 year
Overall evaluation by the investigator of the hemostatic effectiveness of turoctocog alfa (NovoEight®) for the prevention of hemorrhagic complications in a surgical setting (excellent, good, fair, poor/none according to recommendations of the SSC of ISTH)
次要结局
- Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors.(1 year)
- Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)(1 year)