Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate Traumatic Brain Injury

Intervention / Treatment
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* Device: Intracranial pressure monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICP monitoring group<br>patients received ICP monitoring | Device: Intracranial pressure monitoring<br>* An invasive method to monitor the intracranial pressure of patient<br>|
| conventional treatment group<br>patients without ICP monitoring and received conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good neurologic outcome | The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury | Within 6 months after traumatic brain injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months mortality | The mortality of patients in each group at 6 months after traumatic brain injury | Within 6 months after traumatic brain injury | 
| In-hospital mortality | The mortality of patients in each group during hospitalization | Within 1 month after traumatic brain injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Pressure