NCT06083792

Brief Summary

Severe traumatic brain injury (sTBI) is a critical disease of public health importance. Increased intracranial play a significant role in the secondary injury of TBI. Reducing the ICP is helpful in reducing the mortality of sTBI. The threshold of ICP for sTBI has been suggested. The threshold of ICP for sTBI after decompressive craniectomy is not clear.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

October 9, 2023

Last Update Submit

October 9, 2023

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Modified Glasgow Outcome score

    neurological outcome

    180 days after injury

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

240 patients

You may qualify if:

  • history of traumatic brain injury age: 18-80 years admission GCS score≤8 admitting to hospital with 24 hours after injury received decompressive craniectomy received invasive ICP monitoring

You may not qualify if:

  • refuse follow-up received operation before admitting to hospital received cardio-pulmonary resuscitation after injury disturbance of consciousness caused by non-traumatic reasons prior history of traumatic brain injury or stroke expected lifetime less than 180 days admitting to other ongoing study systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Yan Qu

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong Li

CONTACT

+86-13709183909409615390@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 16, 2023

Study Start

October 8, 2023

Primary Completion

July 30, 2025

Study Completion

December 30, 2025

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR