NCT02742857已完成1 期
Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reversal of brain death as noted in clinical examination or EEG
研究概览
简要总结
This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI
- •Not willing for organ donation
- •Written informed consent from the legally acceptable representative of the patient
排除标准
- •Metallic clips/ metal implants or intracranial implants in the brain.
- •Pregnancy
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Reversal of brain death as noted in clinical examination or EEG
时间窗: 15 days
次要结局
- Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation(15 days)
- MRI analysis to analyze any changes in meninges(15 days)
- O2 saturation(15 days)
- Pulse(15 days)
- Blood Pressure(15 days)
- Respiration changes(15 days)
研究者
研究点 (2)
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