Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

Recruiting now · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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 randomized control trial will be conducted. Participants with a radiological diagnosis of traumatic intracerebral hemorrhage/contusions and an initial GCS score of 5-12 will be screened and enrolled in the first 24 hours after traumatic brain injury.

Key facts

Study ID

NCT06065046

Run by

Tang-Du Hospital

People needed

100

Starts

2023-11-24

Expected to finish

2026-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tandu Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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