Sponsor study identifier
observational
200
1 country
1
Study Start
June 1, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Traumatic brain injury (TBI) is a serious global health problem, with about 27 million new cases each year. Severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. Intracranial pressure monitoring is key to modern TBI treatment, but this approach does not fully reflect all relevant pathophysiological changes. Multimodal monitoring allows for a more comprehensive assessment of the severity of TBI and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. Although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. Future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with TBI.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2024
Actual (reported)September 1, 2024
Actual (reported)September 3, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Glasgow Outcome Score-Extended at 6 months
Glasgow Outcome Score-Extended at 6 months
6 months
All patients will be monitored for baseline TCD at admission and at least once a day during treatment to assess changes in cerebral blood flow dynamics. Brain Oxygen Monitoring, Equipment \& Frequency: Continuous monitoring of partial pressure of oxygen (PbtO2) in brain tissue using near-infrared spectroscopy (NIRS). qEEG monitoring,Frequency and timing of monitoring. Baseline monitoring: All patients will undergo a baseline qEEG test at the time of admission. Continuous monitoring: In the ICU, for critically ill patients, qEEG will be performed continuously to monitor changes in EEG activity in real time. Monitoring brain activity: qEEG is able to detect subtle changes in brain waves that can be used to assess brain functional status, such as EEG quiescence, abnormal electrical discharges (e.g., epileptiform activity), etc. Abnormal parameters: focus on abnormal rhythms (e.g., high-amplitude slow-wave activity), acute asymmetric activity, and epileptiform discharge.
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Traumatic brain injury
Xiangya Hospital
Changsha, Hunan, 410008, China
First Submitted
September 1, 2024
First Posted
September 3, 2024
Study Start
June 1, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 3, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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