Severe Brain InjuryCSBITNCT06179836
Chinese Severe Brain Injury Trial
An observational study of Severe Brain Injury, run by Xuanwu Hospital, Beijing.
Trial summary
Building a Large Chinese Cohort(Chinese Severe brain injury Trial） Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Brain Injury
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with impaired consciousness with a clear cause of brain injury.
Who may be able to join
- a clear cause of brain injury
- disorders of consciousness, GCS≤12
- within six months of onset
Who cannot join
- not applicable
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
Building a Large Chinese Cohort(Chinese Severe brain injury Trial）
- Conditions
- Severe Brain Injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| good prognosis group | Not described | |
| poor prognosis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale
The unabbreviated scale title is Glasgow Outcome Scale. GOS includes a score of 1-5, with the higher the score, the better the prognosis.
Measured: 6 months after severe Brain Injury
Secondary outcomes (1)
Glasgow Outcome Scale
The unabbreviated scale title is Glasgow Outcome Scale. GOS includes a score of 1-5, with the higher the score, the better the prognosis.
Measured: 3 months and 12 months after severe Brain Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Brain InjuryStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179836
- Sponsor's protocol ID
- CSBIT
- Acronym
- CSBIT
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Severe Brain Injury Trial
- ClinicalTrials.gov ID
- NCT06179836
- Acronym / sponsor ID
- CSBIT / CSBIT
- Conditions
- Severe Brain Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Dec 2023 (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.
Building a Large Chinese Cohort(Chinese Severe brain injury Trial）
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good prognosis group | – | – |
| poor prognosis group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with impaired consciousness with a clear cause of brain injury.
Key inclusion criteria (3 listed)
- a clear cause of brain injury
- disorders of consciousness, GCS≤12
- within six months of onset
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Scale
Time frame: 6 months after severe Brain Injury
The unabbreviated scale title is Glasgow Outcome Scale. GOS includes a score of 1-5, with the higher the score, the better the prognosis.
1 secondary outcome
Glasgow Outcome Scale
Time frame: 3 months and 12 months after severe Brain Injury
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 22 Dec 2023.
- Individual participant dataSharing planned: No
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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 Severe Brain Injury, run by Xuanwu Hospital, Beijing.
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 3 inclusion and 1 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 22 Dec 2023. 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 Zhang Yan, MD (13671376710, zhangylq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale (time frame: 6 months after severe Brain Injury). 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 22 Dec 2023; AzTrials last refreshed its copy on 3 Nov 2026.