Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

Recruiting

• Conditions: Moderate Traumatic Brain Injury
• Interventions: Device: Intracranial pressure monitoring

• Registration Number: NCT04900168
• Lead Sponsor: Tang-Du Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-05-23
• Study First Posted: 2021-05-25
• Study Start: 2021-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 832

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICP monitoring group	Intracranial pressure monitoring	patients received ICP monitoring

Primary Outcome Measures

Name	Time	Method
Good neurologic outcome	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

Secondary Outcome Measures

Name	Time	Method
6 months mortality	Within 6 months after traumatic brain injury	The mortality of patients in each group at 6 months after traumatic brain injury
In-hospital mortality	Within 1 month after traumatic brain injury	The mortality of patients in each group during hospitalization

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shannxi Province, China