Monitoring intracranial pressure in patients with moderate traumatic brain injury
Official title: 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
Run by Tang-Du Hospital · NCT04900168 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Tang-Du Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi Province) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT04900168 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with penetrating head injuries, severe comorbid conditions, or those who refuse follow-up visits may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Tangdu Hospital
Xi'an, Shannxi Province, China Recruiting
Study contacts
- Study coordinator: Zhihong Li, Doctor
- Email: 409615390@qq.com
- Phone: +81-029-84717821
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.