Evaluation and Correlation Between the Disruption in Blood-brain-barrier and the Development of Secondary Brain Edema Associated With Brain Damage by Using MRI in Patients With Various Types of Intra-cranial Bleeding
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- delayed peri - hemorrhage edema as a relation to early BBB disruption
研究概览
简要总结
MRI research Group in the Advanced Technology Center of the Sheba Medical Center has developed an innovative methodology based on leakage (extravasation) contrast agent that allows to map the entire brain with high resolution and high sensitivity to check and describe disorders BBB (blood brain barrier).
The aim of the current study is to evaluate the feasibility of the BBB disruption detection method to predict delayed peri - hemorrhage edema.
详细描述
Research's Protocol:
Evaluation and Correlation between the disruption in blood-brain-barrier and the development of secondary brain edema associated with brain damage by using MRI in patients with various types of intra-cranial bleeding .
Research team:
Main (Primary researcher):
Sagi Harnof MD , Neurosurgery department, Sheba medical center, Tel Hashomer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 years.
- •patient is able to sign the informed consent form.
- •Spontaneous brain hemorrhage ICH in the last12 hours ( pre- admission,or sub- dural bleeding (whether acute or chronic ).
排除标准
- •The patient meets a contraindication to undergo MRI.
- •The patient is too unstable to undergo MRI
- •The patient is a candidate for surgery within 24 hours.
研究组 & 干预措施
spontaneous ICH bleeding
An initial Baseline MRI is to be done within 6-24 hours from the bleeding. second MRI which serves as review - on the 3rd -5th day after bleeding
干预措施: MRI (Device)
chronic sub dural bleeding
An initial Baseline MRI is to be done at the time of diagnosis. second MRI which serves as review -within two weeks.
干预措施: MRI (Device)
acute sub-dural bleeding
An initial Baseline MRI is to be done within 6-24 hours from the bleeding. second MRI which serves as review - within two weeks.
干预措施: MRI (Device)
结局指标
主要结局
delayed peri - hemorrhage edema as a relation to early BBB disruption
时间窗: 1 week
early BBB disruption will be calculated from Gad enhanced magnetic resonance (MR) and a correlation to late volume of edema as calculated using 3D methods will be assessed
次要结局
未报告次要终点
研究者
Dr. Sagi Harnof
M.D.
Sheba Medical Center