Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions (NCT06065046) | Clinical Trial Compass
RecruitingPhase 2
Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions
China100 participantsStarted 2023-11-24
Plain-language 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 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.)