Traumatic Brain Injury
Conditions
Interventions
Conventional treatment group:Pharmacotherapy
supportive therapy
monitoring and evaluation
prevention of complications
placebo, 200 mg/day, orally administered, maintained for three months.
The conventional treatment combined with fenofibrate adjuvant therapy group:Conventional treatment was identical to that in the conventional treatment group
fenofibrate, 200 mg/day, administered orally, maintained for three months
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with TBI through medical history collection and imaging (CT, etc.); 2. Age > 65 years, regardless of gender; 3. Time from onset to surgery <= 72 hours, with no postoperative complications such as intracranial rebleeding or intracranial infection; 4. Stable postoperative condition, with normal basic vital signs and sufficient consciousness to cooperate with behavioral assessments; 5. Essentially normal liver and kidney function, or mild abnormalities that do not affect drug metabolism and excretion at the study dosage, with ALT and AST <= 2 times the upper limit of normal and serum creatinine <= 1.5 times the upper limit of normal; 6. Signed informed consent obtained from the patient or their legal representative (particularly for patients with potential cognitive impairment).
Exclusion criteria
Exclusion criteria: 1. Non-supratentorial intracerebral hemorrhage; secondary intracerebral hemorrhage (secondary causes such as aneurysm, vascular malformation, hemorrhagic transformation of cerebral infarction, tumor, drug-related or coagulation disorders, etc.); patients with cerebral herniation; severe TBI or severe skull base fracture; 2. Concurrent other neurological disorders: such as Alzheimer's disease, Parkinson's disease, history of stroke, intracranial tumors, etc.; 3. Concurrent severe psychiatric disorders: such as schizophrenia, bipolar disorder, or depression, etc.; 4. Concurrent end-stage organ failure: such as NYHA class IV heart failure, renal failure requiring dialysis, etc.; 5. Current use of other fibrates or statins; 6. Current use of medications that may affect cognition: such as long-term benzodiazepines or anticholinergic drugs; 7. Allergy to the study drug; 8. Abnormal cardiac, hepatic, or renal function, or history of cardiac, hepatic, or renal diseases; 9. Patients who may become pregnant in the near future, are already pregnant, are lactating, or refuse contraception within six months of drug administration; those with intrauterine device pregnancy or suspected ectopic pregnancy; 10. Inability to complete cognitive assessments: such as severe visual/hearing impairment or limb paralysis affecting the operation of the Trail Making Test; 11. Poor compliance: such as history of alcoholism, drug abuse, or inability to cooperate with follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trail Making Test B; | — |
Secondary
| Measure | Time frame |
|---|---|
| Trail Making Test A; | — |
Countries
China
Contacts
Public ContactWei Shi
Affiliated Hospital of Nantong University
Outcome results
None listed