To assess the effect of Febuxostat on clinical outcomes and biomarkers of oxidative stress and inflammation in patients with conservatively managed intracranial hemorrhage.
• Age ≥ 18 years old.
Diagnosed with intracranial hemorrhage confirmed by CT scan.
Managed conservatively regarding clinical guidelines.
Able to provide informed consent or have a legal representative provide consent.
• Patients with a history of previous brain surgery or significant neurological disorders.
Severe comorbidities (e.g., uncontrolled diabetes, severe cardiac disease).
Allergy or contraindication to febuxostat.
Pregnant or breastfeeding women.
Parallel
Febuxostat 40 mg
DrugParticipants in this arm will receive Febuxostat at a dose of 40 mg orally once daily for a duration of three months, administered in addition to the standard traditional therapy for conservatively managed intracranial hemorrhage
Standard medical treatment
DrugParticipants in this arm will receive only the standard traditional medical guidelines and therapy for conservatively managed intracranial hemorrhage for a duration of three months
Change from baseline in glasgow coma scale
The GCS is used to assess the patient's level of consciousness based on eye, verbal, and motor responses, with a total score ranging from 3 (severe impairment) to 15 (normal). Higher scores indicate better clinical outcomes
Radiological assessment via non-contrast computed tomography (NCCT)
NCCT imaging will be used to evaluate hematoma stability, resolution, expansion, or complications (such as perihematomal edema, mass effect, or midline shift) in intracranial hemorrhage patients.
Change from baseline in C-reactive protein (CRP) level at 3 months
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include: C-reactive protein (CRP) level ( mg/l)
Change from baseline in Erythrocyte sedimentation rate (ESR) at 3 months.
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include: Erythrocyte sedimentation rate (ESR) (mm/hr)
Change from baseline in Serum Interleukin-1 beta (IL-1β) at 3 months.
Blood samples will be analyzed to measure the change in levels of specific inflammatory biomarkers to evaluate the effect of Febuxostat on neuroinflammation and oxidative stress. The biomarkers include: Interleukin-1 beta (IL-1β) (pg/mL).
Click on the lead sponsor to view all of their trials.
