Aneurysmal Subarachnoid Hemorrhage
Conditions
Interventions
Placebo + standard treatment group (control group):Placebo + standard treatment
Methylprednisolone sodium succinate + standard treatment group (Experimental group):Methylprednisolone sodium succinate + standard treatment
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Over 18 years old; 2.Primary aSAH via imaging examinations with the modified Fisher's grading assessment (Grade 1-4); 3.WFNS grade 2-4; 4.Within 72 hours of onset; 5.The legal representative of the patient signs a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients with clear evidence of irreversible brainstem or thalamic damage; 2.SAH caused by other reasons (such as trauma, arteriovenous malformations, etc.); 3.Known to be allergic to methylprednisolone or drugs with similar chemical structures; 4.Those who can be foreseen to be unable to fully complete the follow-up plan (such as suffering from mental illness, etc.); 5.Any serious diseases that, after assessment, may interfere with the test results, including diseases of the respiratory system, circulatory system, digestive system, urogenital system, endocrine system, immune system and blood system, etc; 6.There has been a history of bleeding (gastrointestinal and urinary tract bleeding) in the past month; 7.Systemic infectious diseases or active local infections (including but not limited to pneumonia, urinary tract infections, skin and soft tissue infections, etc.); 8.Those with glaucoma or macular edema; 9.Patients who have been using glucocorticoids for a long time before the onset of the disease; 10.The life expectancy caused by the advanced stage of any disease is less than 12 months; 11.Pregnant or lactating women; 12.Currently participating in other clinical trials; 13.The patient or his/her legal guardian is unwilling to sign the written informed consent form; 14.Any situation that may cause harm to the patient after the start of the research treatment or affect the patient's participation in the research;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomized mortality within 180 days;Randomized 180-day good prognosis rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of DCI;Quality of life assessment;Randomize the mRS Score at 180 days;Incidence of symptomatic cerebral vasospasm;Randomized 180-day excellent prognosis rate;Randomized 180-day superb prognosis rate;The incidence, severity and correlation with the study drug of adverse events (AE) and serious adverse events (SAE) during the treatment period;Specific adverse reactions related to methylprednisolone sodium succinate; | — |
Countries
China
Contacts
Public ContactZhi Chen
The First Affiliated Hospital of Army Medical University
Outcome results
None listed