Status:
UNKNOWN
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Lead Sponsor:
Tang-Du Hospital
Conditions:
Moderate Traumatic Brain Injury
Eligibility:
All Genders
18-75 years
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
832 Patients enrolled
Trial Details
Trial ID
NCT04900168
Start Date
June 1 2021
End Date
June 30 2024
Last Update
July 27 2023
Active Locations (1)
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1
Tangdu Hospital
Xi'an, Shannxi Province, China