The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups
研究概览
简要总结
The aim of this study is to investigate the early serum measurement (<6h after injury) of mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions (CCT neg.).
S100B serum levels will be measured in both groups. The usual risk factors for the occurrence of an intracranial hematoma (diagnostic algorithm) will be recorded. Additionally, a group of healthy individuals will serve as a control group.
During the study, technical and scientific capabilities and options increased and two further mRNA´S (miR-124-3p and miR-9-5p) will be investigated, too.
详细描述
Patients and Methods
The investigators plan to include 60 patients with minor head injury (MHI) admitted to our hospital within one year (1-2 each week):
1. 30 patients in the CCT pos. group, i.e. patients with an intracranial hematoma on emergency CT scan. 2. 30 patients with MHI in the CCT neg. group, i.e. patients without an intracranial traumatic lesion on emergency CT-scan. 3. Additionally, 30 healthy volunteers will be included.
Patients with multiple injuries i.e. polytraumatized patients, patients with severe traumatic brain injury, patients with open fractures and fractures of the long bones, as well as pregnant patients and patients <18 years, are excluded from the study.
Patients with a GCS (Glascow Coma Scale) of 13-15 are usually able to consent to be enrolled in the clinical trial. Generally, their reasoning and judgment is not impaired.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •TBI with GCS 13-15
排除标准
- •Patients with multiple injuries i.e. polytraumatized patients, patients with severe traumatic brain injury, patients with open fractures and fractures of the long bones, as well as pregnant patients and patients <18 years, are excluded from the study.
研究组 & 干预措施
Minor head injury CCT pos. group
Tbi patients with acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.
干预措施: Drawing of 7ml peripheral blood (Procedure)
Minor head injury CCT neg. group
Tbi patients without acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.
干预措施: Drawing of 7ml peripheral blood (Procedure)
Control Group (healthy volunteers)
Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn.
干预措施: Drawing of 7ml peripheral blood (Procedure)
结局指标
主要结局
Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups
时间窗: 6 hours
non of the measured biomarker shows a significant difference between the 3 study groups
次要结局
未报告次要终点
研究者
Harald Wolf, MD
Oberarzt Dr. Harald Wolf
Medical University of Vienna