Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic intracerebral Hemorrhage, traumatic intracerebral Contusions, baricitinib, Janus kinase inhibitor, neuro-inflammatory responses
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Tandu Hospital, Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Control group
Baricitinib 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)
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.