Overview
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. 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.
Sample Size and Population Sample size calculation: Not applicable. The sample size will be equal to the total number of moderate trumatic brain injury patients consecutively admitted to hospitals during the study period.
Eligibility
Inclusion Criteria:
- History of head trauma
- 18 ≤ age ≤ 75 years
- Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
- Glasgow coma scale at admission: 9-13
- No pregnant
Exclusion Criteria:
- Refusing follow up visit
- Surgical treatment in other hospital before admission
- Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
- 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.
