Monitoring intracranial pressure in patients with moderate traumatic brain injury
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
This study is testing if keeping track of pressure inside the skull can help people with moderate traumatic brain injury in China recover better compared to those who don't have this monitoring.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 832 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tang-Du Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi Province) |
| Trial ID | NCT04900168 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether monitoring intracranial pressure (ICP) can improve treatment outcomes for patients with moderate traumatic brain injury (TBI) in China. It involves a multi-center approach where patients will be evaluated based on their neurological outcomes at six months post-injury using the extended Glasgow outcome score (GOSE). The decision to monitor ICP will be made by the patients' relatives, and treatment will follow existing protocols in participating hospitals. The study will compare outcomes between patients who receive ICP monitoring and those who do not.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with moderate TBI, as indicated by a Glasgow coma scale score of 9-12 and abnormal head CT findings.
Not a fit: Patients with penetrating head injuries, severe comorbid conditions, or those who refuse follow-up visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with moderate TBI, potentially enhancing recovery outcomes.
How similar studies have performed: While the approach of ICP monitoring is established, this specific observational study's outcomes in the context of moderate TBI are novel and have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shannxi Province
- Tangdu Hospital — Xi'an, Shannxi Province, China (Recruiting)
Study contacts
- Study coordinator: Zhihong Li, Doctor
- Email: 409615390@qq.com
- Phone: +81-029-84717821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.