Baricitinib for moderate-to-severe intracerebral bleeding and contusions after head injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, phase 2 trial comparing oral baricitinib plus standard treatment versus standard treatment alone in adults with CT-confirmed traumatic intracerebral hemorrhage or contusions. Eligible patients have closed head injury, a Glasgow Coma Scale score of 5–12, and are enrolled within 24 hours of injury. The intervention uses baricitinib 4 mg in addition to routine care, and outcomes compare clinical recovery and neurologic status between groups. The study is grounded in preclinical data showing JAK1/2 inhibition reduces post‑traumatic neuroinflammation and edema, and in clinical experience with baricitinib in other inflammatory conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years older and younger than 80 years old.
2. Definite history of traumatic brain injury.
3. Admission within≤24 hours after the traumatic brain injury.
4. CT scans demonstrate intracerebral hemorrhage/contusions with and without extracerebral hemorrhage (epi- and sub- dural hemorrhage)
5. GCS score of 5 or greater and no more than 12 at time of enrollment.
6. Closed head injury.
7. Admission without infections
8. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.

Exclusion Criteria:

1. Time of head injury cannot be reliably assessed.
2. Subjects is considered a candidate for immediate surgical intervention because of severe extracranial injury.
3. Open head injury.
4. Pregnancy or parturition within previous 30 days or active lactation.
5. Use of Janus kinase inhibitors (baricinitib,abroctinib, AG490 and etc.)
6. Pre-traumatic dementia or disability.
7. With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
8. Severe pulmonary infection.
9. Severe or acute heart failure.
10. Severe infections within previous 30 days.
11. History of myocardial infarction.
12. Known sensitivity to baricinitib.
13. Severe decreases in neutrophil, lymphocyte and platelet counts, severe decrease in hemoglobin.
14. Severe liver and kidney dysfunction.
15. Currently participating in other interventional clinical trials.

Where it's running

• Tandu Hospital, Fourth Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Shunnan Ge, M.D,Ph.D
• Email: gesn8561@fmmu.edu.cn
• Phone: +8618165295569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.