Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no)
研究概览
简要总结
This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.
详细描述
Hemorrhagic stroke caused by an intracerebral hemorrhage (ICH) is a common (roughly 15% of all strokes) and devastating disease with high rates of mortality and morbidity. The most important potentially modifiable prognostic factor after acute diagnosis of an ICH is hematoma expansion.
The investigators hypothesize that in hyperacute ICH patients a treatment target can be detected with a diagnostic, cerebral DSA. The DSA is the goldstandard for the visualization of brain vessels. A treatment target would be a vessel from which contrast media extravasates as a sign of an active bleeding. If such a target could be identified, it could lay the rationale for future trials which would evaluate if stopping the bleeding directly at the origin improves patient outcomes. The only intervention in this study is an additional diagnostic cerebral DSA. This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
A person blinded to all clinical data will assess the primary endpoint.
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
- •Diagnosis of an acute spontaneous ICH based on non-contrast CT
- •Time from symptom onset to anticipated start of cerebral DSA of under 3 hours
- •Agreement of the treating physician to perform DSA
- •Informed consent documented by signature or fulfilling the criteria for emergency consent procedures (deferral of consent)
排除标准
- •High probability that the etiology of the bleeding is a ruptured aneurysm, an arteriovenous malformation or an amyloid angiopathy as judged by the treating physician
- •Any time critical surgical or minimal invasive intervention is planned
- •Evidence of an ongoing pregnancy, a negative pregnancy test is mandatory in all persons of childbearing potential
- •Contraindications against the use of iodine contrast media
- •Known severe kidney insufficiency (Glomerular filtration rate < 30 ml/min)
结局指标
主要结局
Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no)
时间窗: one time assessment at baseline (duration of the DSA will be 15 to 20 minutes)
Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no). It is defined by a ruptured artery which fulfills the following two criteria: 1. Extravasate of contrast media into the surrounding tissue, and 2. Potentially reachable by a (micro-)catheter which can be used for treatment (i.e., local infusion of a procoagulant medication or (temporary) occlusion of the ruptured artery).
次要结局
未报告次要终点