Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

Sponsor
Tang-Du Hospital
Study ID
NCT06065046
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib 4 MG — DRUG
    Baricitinib with be be administrated orally (or crushed for nasogastric tube delivery) and given daily at the dosage of 4mg for consecutive 14 days
  • Standard treatment — OTHER
    Patients will receive standard treatment and care according to the current management guidelines for traumatic brain injury.

Study Details

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 Dates

Start date
Nov 24, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Control group
    Participants will receive standard treatment and care according to the current management guidelines for traumatic brain injury, e.g. the guideline made by U.S. Brain Trauma Foundation (BTF)
  • Experimental: Baricitinib group
    Besides receiving standard treatment and care, baricitinib will be administrated orally (or crushed for nasogastric tube delivery) and given daily at the dosage of 4mg, for consecutive 14 days after patients' brain injury.

Primary Outcome Measure

Clinical improvement [ Time Frame: up to 180 days ]

Central Contacts

Related Studies