Acute Brain InjuryNCT06505213
Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury
An observational study of Acute Brain Injury, run by Xiangya Hospital of Central South University.
Trial 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 injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- How many people
- 490 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2024to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Critically Ill, Acute Brain Injury Adult Patients.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 injuries. This research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.
Read the 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 critical timing required for effective intervention. Multimodal brain monitoring, which integrates various physiological data points like brain electrical activity, cerebral blood flow, and brain tissue oxygenation, offers a comprehensive view of a patient's cerebral status. This study builds on the premise that a better understanding and real-time monitoring of these variables can significantly improve patient outcomes by enabling timely and targeted interventions.
- Conditions
- Acute Brain Injury
- Being tested
- no intervention
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between multimodal brain monitoring parameters and outcome.
Association between advanced multimodal brain monitoring parameters of the first 48h of admission and six months functional outcome (Glasgow Outcome Score Extended)
Measured: 6 months
Secondary outcomes (2)
Neuromonitoring Pattern
Describe multimodal neuromonitoring parameters variation and identify trends.
Measured: 3-5 days
Neuromonitoring and Short Term Outcome
Association between advanced multimodal brain monitoring parameters and 28 days functional outcome (Glasgow Outcome Score Extended)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505213
- Sponsor's protocol ID
- 2024070747
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06505213
- Acronym / sponsor ID
- 2024070747
- Conditions
- Acute Brain Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 injuries. This research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.
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 critical timing required for effective intervention. Multimodal brain monitoring, which integrates various physiological data points like brain electrical activity, cerebral blood flow, and brain tissue oxygenation, offers a comprehensive view of a patient's cerebral status. This study builds on the premise that a better understanding and real-time monitoring of these variables can significantly improve patient outcomes by enabling timely and targeted interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically Ill, Acute Brain Injury Adult Patients.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Relation between multimodal brain monitoring parameters and outcome.
Time frame: 6 months
Association between advanced multimodal brain monitoring parameters of the first 48h of admission and six months functional outcome (Glasgow Outcome Score Extended)
2 secondary outcomes
Neuromonitoring Pattern
Time frame: 3-5 days
Neuromonitoring and Short Term Outcome
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury, run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Le Zhang (+8613973187150, zlzdzlzd@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between multimodal brain monitoring parameters and outcome. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.