Feasibility Assessment of CEREBOⓇ in conjunction with CEREBOⓇ Research Unit (CCRU)to detect structural and functional injury among brain injury patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To assess the structural and functional injury in traumatic brain injury patients
研究概览
简要总结
This clinical study employs a quasi-experimental design with a randomized controlled trial to assess the efficacy of CEREBO® in conjunction with the CEREBO® Research Unit for traumatic brain injury management. The study will evaluate the clinical performance of the device in assessing structural and functional injuries in traumatic brain injury patients. Additionally, it will compare the reduction in transfer time to the first head CT scan between the experimental and control groups. The study also focuses on assessing the impact of early detection of brain injuries, thereby aiding in the development of tailored rehabilitation strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Traumatic and non-traumatic patients who are referred for a head CT or an MRI scan.
- •Suspected CVA or infarct.
排除标准
- •History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.
- •Post-Operative patients.
结局指标
主要结局
To assess the structural and functional injury in traumatic brain injury patients
时间窗: 3 years
次要结局
- Reduction in the mean transfer time from injury to first head CT Scan(3 years)
研究者
Dr Vijaya Sekhar M V
Government General Hospital