Traumatic brain injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with TBI through medical history collection and imaging (such as CT) with a GCS score 30 ml; 2. Patients over 65 years old, regardless of gender; 3. Time from onset to surgery <=72 hours, and no complications such as intracranial rebleeding or intracranial infection after surgery; 4. Meeting the diagnostic criteria for hospital-acquired pneumonia (HAP): specific indicators may include: clinical manifestations: fever, cough, purulent sputum, etc.; respiratory-related symptoms: tachypnea or hypoxemia; laboratory and imaging evidence: pulmonary infiltration or lesions shown on chest imaging; elevated or decreased white blood cell count in blood routine, elevated C-reactive protein (CRP) or procalcitonin (PCT); positive results from sputum culture or other microbiological tests; 5. Stable postoperative condition with stable basic vital signs; 6. BALF flow cytometry: proportion of HLA-DR+ neutrophils < 2%; 7. Basic liver and kidney functions are normal or only slightly abnormal, which do not affect drug metabolism and excretion at the study dose, with ALT and AST <= 2 times the upper limit of normal and serum creatinine <= 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Non-supratentorial intracerebral hemorrhage; 2. Secondary intracerebral hemorrhage (secondary causes such as aneurysms, vascular malformations, hemorrhagic transformation of cerebral infarction, tumors, drug-related or abnormal coagulation mechanisms, etc.); patients with brain herniation; 3. Severe TBI or with severe basilar skull fractures; 4. TBI patients with concurrent injuries to other organs; 5. Patients judged by the researcher to have poor compliance, mental problems preventing informed consent, or whose families refuse to participate in the study; 6. Patients allergic to this drug; 7. Patients with abnormal heart, liver, or kidney function, or with a history of heart, liver, or kidney diseases; 8. Patients who may be pregnant in the near future, are already pregnant, are in the lactation period, or refuse to use contraception within six months of administration; patients with intrauterine device pregnancy and suspected ectopic pregnancy; 9. Patients with a history of uncontrollable infection or severe infectious diseases; 10. Patients who have received a vaccine within 30 days of administration; 11. Patients currently with diabetes, cardiovascular diseases, a history of pulmonary diseases, immunodeficiency diseases, or other serious diseases that may interfere with outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of negative conversion rate of bacterial culture in BALF after mifepristone treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of HLA-DR+ neutrophils in BALF;Expression of inflammatory factors in BALF;Body temperature;Respiratory function index: FEV1, FVC;Chest computed tomography; | — |
Countries
China
Contacts
Affiliated Hospital of Nantong University