Status:
RECRUITING
Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
Qianxian People's Hospital
Chongqing Hospital of PAP
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of the present study is to study the effect of baricitinib administration on outcome of participants with moderate and severe traumatic intracerebral hemorrhage/contusions. A multi-center ...
Detailed Description
Traumatic brain injury (TBI) remains one of the biggest public health problems and represents a major cause of death or severe disability in young people and adults. Previous studies have confirmed th...
Eligibility Criteria
Inclusion
- Age 18 years older and younger than 80 years old.
- Definite history of traumatic brain injury.
- Admission within≤24 hours after the traumatic brain injury.
- CT scans demonstrate intracerebral hemorrhage/contusions with and without extracerebral hemorrhage (epi- and sub- dural hemorrhage)
- GCS score of 5 or greater and no more than 12 at time of enrollment.
- Closed head injury.
- Admission without infections
- Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
Exclusion
- Time of head injury cannot be reliably assessed.
- Subjects is considered a candidate for immediate surgical intervention because of severe extracranial injury.
- Open head injury.
- Pregnancy or parturition within previous 30 days or active lactation.
- Use of Janus kinase inhibitors (baricinitib,abroctinib, AG490 and etc.)
- Pre-traumatic dementia or disability.
- With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
- Severe pulmonary infection.
- Severe or acute heart failure.
- Severe infections within previous 30 days.
- History of myocardial infarction.
- Known sensitivity to baricinitib.
- Severe decreases in neutrophil, lymphocyte and platelet counts, severe decrease in hemoglobin.
- Severe liver and kidney dysfunction.
- Currently participating in other interventional clinical trials.
Key Trial Info
Start Date :
November 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06065046
Start Date
November 24 2023
End Date
December 31 2026
Last Update
June 4 2025
Active Locations (1)
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1
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710038