NCT04900168 Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
| NCT ID | NCT04900168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tang-Du Hospital |
| Condition | Moderate Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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. Sample Size and Population Sample size calculation: Not applicable. The sample size will be equal to the total number of moderate trumatic brain injury patients consecutively admitted to hospitals during the study period.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04900168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Moderate Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04900168 currently recruiting?
Yes, NCT04900168 is actively recruiting participants. Contact the research team at 409615390@qq.com for enrollment information.
Where is the NCT04900168 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT04900168 clinical trial?
NCT04900168 is sponsored by Tang-Du Hospital. The trial plans to enroll 1,000 participants.