Chinese Severe Brain Injury Trial (CSBIT)

December 20, 2023 updated by: Xuanwu Hospital, Beijing
Building a Large Chinese Cohort(Chinese Severe brain injury Trial）

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with impaired consciousness with a clear cause of brain injury.

Description

Inclusion Criteria:

  • a clear cause of brain injury
  • disorders of consciousness, GCS≤12
  • within six months of onset

Exclusion Criteria:

  • not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
good prognosis group
poor prognosis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after severe Brain Injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Outcome Scale
Time Frame: 3 months and 12 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.
3 months and 12 months after severe Brain Injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSBIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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