Status:
NOT_YET_RECRUITING
Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury
Lead Sponsor:
Xiangya Hospital of Central South University
Conditions:
Acute Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
The primary aim of this study is to evaluate the effectiveness of multimodal brain monitoring technologies as both an early warning system and a prognostic tool in patients suffering from acute brain ...
Detailed Description
Acute brain injury, including traumatic brain injury (TBI) and stroke, presents significant challenges in clinical management, primarily due to the complexity of the brain's response to injury and the...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Must be 18 years of age or older.
- Diagnosed with Traumatic Brain Injury (TBI) or has suffered from acute brain injury due to intracranial hemorrhage or subarachnoid hemorrhage.
- Defined as an admission Glasgow Coma Scale (GCS) Eye Response score of 1 (unable to open eyes) and a GCS Motor Response score of ≤5 (unable to obey commands).
- Occurs within 48 hours of admission, where the patient does not open eyes and motor score drops to 5 or below.
- Exclusion Criteria
- Patients who were not admitted to the Intensive Care Unit (ICU) are excluded.
- Patients with forms of acute brain injury other than those specified (TBI, intracranial hemorrhage, subarachnoid hemorrhage) are also excluded.
- Patients with known severe liver or kidney dysfunction are excluded.
- Patients whose vital signs are extremely unstable after admission, with a very poor prognosis and considered unable to survive, and whose family has decided to forgo further treatment.
- Patients who had a Modified Rankin Scale greater than 2 before the onset of the current illness.
- Patients with a history of congenital or acquired hemorrhagic diseases, coagulation factor deficiencies, or thrombocytopenic disorders.
- Pregnant or lactating women, as well as those planning to become pregnant within the next 90 days.
- Patients with severe psychiatric disorders or dementia who are unable to provide informed consent or complete follow-up requirements.
- Patients who have participated in other interventional clinical trials within 30 days prior to randomization, or who are currently participating in other clinical research.
- Any other reasons that the researcher deems unsuitable for participation in this trial.
Exclusion
Key Trial Info
Start Date :
July 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT06505213
Start Date
July 30 2024
End Date
June 30 2028
Last Update
July 17 2024
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