A Multi-center Observational Cohort Study of Management of Moderate Traumatic Brain Injury With or Without Intracranial Pressure Monitoring in Patients With Moderate Traumatic Brain Injury in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- Good neurologic outcome
研究概览
简要总结
Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China.
Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. It is a 2-group design. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months.
Interventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension. Each patient will be evaluated at 6 months post injury on neurological outcomes.
Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of head trauma
- •18 ≤ age ≤ 70 years
- •Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
- •Glasgow coma scale at admission: 9-12
- •Arriving at hospital within 24 hours after injury
- •Systolic blood pressure ≥100 millimeter of mercury
- •No pregnant
排除标准
- •Refusing follow up visit
- •Penetrating head injury, spine or spinal cord injury
- •Surgical treatment in other hospital before admission
- •Cardiopulmonary resuscitation after injury or in need of blood transfusion due to active bleeding
- •Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
- •Prior history of head trauma or stroke
- •Multiple injuries, with severity score of other parts>18
- •Rhabdomyolysis, with blood creatine kinase (CK)>5000 international unit/L
- •Injury of aorta, carotid artery or vertebral artery
- •Serum creatinine (female)>1.2mg/dL (106μmol/L), serum creatinine (male)>1.5mg/dL (133μmol/L)
- •Glomerular filtration rate (eGFR) <60 milliliter/min
- •Body mass index (BMI) <18.5kg/m2 or >40kg/m2
- •Estimated survival time less than 1 year
- •Participating in other on-going clinical researches
- •Other systemic diseases: uremia, liver cirrhosis, malignant tumor, mental illness, drug, or alcohol dependence, etc.
结局指标
主要结局
Good neurologic outcome
时间窗: Within 6 months after traumatic brain injury
The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury
次要结局
- 6 months mortality(Within 6 months after traumatic brain injury)
- In-hospital mortality(Within 1 month after traumatic brain injury)