Registration of Idarucizumab for Patients with IntraCranial Hemorrhage (RIC-ICH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 33
- 主要终点
- Intra-hospital mortality rate
研究概览
简要总结
This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dabigatran-group
Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
干预措施: Dabigatran Etexilate Oral Capsule [Pradaxa] (Drug)
dabigatran-group
Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
干预措施: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND] (Drug)
VKA-group
Patients under effective treatment with VKA and with intracranial hemorrhage.
干预措施: Vitamin K antagonist (Drug)
结局指标
主要结局
Intra-hospital mortality rate
时间窗: From study inclusion until hospital discharge or 30 days after index event, whichever came first.
Intra-hospital mortality rate
次要结局
- Intracranial bleeding(Between 24 and 72 hours after initial CT.)
- Functional status(At hospital discharge or 30 days after index event, whichever came first.)
- Change in National Institutes of Health Stroke Scale (NIHSS)(At hospital admission, 24 hours after admission and 72 hours after admission.)
- Mortality rate(7 and 30 days after index event.)
- Stroke severity(72 hours after hospital admission)
研究者
Prof. Dr. Hans Diener
Senior Professor of Clinical Neurosciences
University Hospital, Essen