Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 382
- 试验地点
- 2
- 主要终点
- Efficacy of Tocilizumab (RoActemra) and Tranexamic acid (Cyklokapron) used as Adjuncts to Chronic Subdural Hematoma Surgery Regarding Postoperative Recurrence
研究概览
简要总结
Primary objectives of the study are to investigate whether adjuvant treatment in the form of Tranexamic acid (Cyklokapron) and Tocilizumab (RoAcmera) to surgery in patients with chronic subdural hematomaina can:
- effectively decrease the rate of lesion recurrence requiring re-operation,
- effectively shorten the time of lesion resolution.
Secondary objectives of the study are:1) assess the postoperative functional outcome and quality of life of participants, 2) assess the postoperative mortality of participants, 3) assess the treatment safety data, 4) assess the cure rate of participants.
详细描述
Primary endpoints in the study are: 1) determine postoperative recurrence requiring reoperation using clinical examination and CT imaging, 2) determine the time period necessary to complete healing using clinical examination and CT imaging.
Secondary endpoints in the study are: 1) to determine the functional outcome and quality of life of the participants using questionnaires, 2) to determine the mortality of the participants related to chronic subdural hematoma, 3) to determine the treatments complications and adverse events of the participants, 4) to determine the curation using clinical examination and CT imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
排除标准
- •patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
结局指标
主要结局
Efficacy of Tocilizumab (RoActemra) and Tranexamic acid (Cyklokapron) used as Adjuncts to Chronic Subdural Hematoma Surgery Regarding Postoperative Recurrence
时间窗: 6 months period after the initial surgery.
To determine the rate in number and percentage of postoperative recurrence requiring re-operation
次要结局
未报告次要终点
研究者
Milo Stanisic
Principal Investigator
Oslo University Hospital