Aneurysmal Subarachnoid Hemorrhage
Conditions
Interventions
Aspirin group:According to the pharmacological properties of aspirin enteric-coated tablets, oral or rectal administration will be the experimental intervention in this trial. For conscious patients w
Placebo control group:According to the pharmacological properties of aspirin enteric-coated tablets, oral or rectal administration will be the experimental intervention in this trial. For conscious pa
Sponsors
Ganzhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old. 2. Spontaneous subarachnoid hemorrhage confirmed by head CT. 3. The diagnosis of cerebral aneurysm is clear and the ruptured aneurysm has been successfully treated by surgical clipping or endovascular interventional embolization within 48 hours. 4.Hunt-Hess score <=4/ WFNS score <=4 (SAH within 24-48 hours of onset) 5.Fisher score 2-4, mFisher score 1-4. (basically any SAH grade) 6. There were no significant focal neurological deficits after aneurysm intervention, including monophasia, hemiplegia, or sensory, motor, or global aphasia. The physician in charge should use their best clinical judgment to determine whether there is a neurologic deficit that could compromise mRS Performance 7. Informed consent was obtained from the patient or family. 8. mRS <= 1 before onset
Exclusion criteria
Exclusion criteria: 1. Patients with SAH of HUNT-Hesse grade 5 or WFNS grade 5 (within 24 to 48 hours of onset); 2. Any intracranial stent or non-embolic device required during aneurysm embolization and antiplatelet therapy after aneurysm embolization 3. Negative angiographic SAH. 4. Previous history of intracranial aneurysm rupture/re-rupture of treated aneurysms is not excluded. 5. Preoperative or intraoperative CTA/DSA showed moderate to severe vasospasm. 6. Other causes of non-saccular aneurysm rupture such as SAH caused by mycotic or blood blister-like, fusiform aneurysms, dissecting aneurysms, or subarachnoid hemorrhage without basal cisterns. 7. Significant intracranial pathological conditions confirmed at the time of enrollment, including but not limited to traumatic, moyamoya disease, highly suspected or documented vasculitis of the central nervous system, severe fibromuscular dysplasia, arteriovenous malformations, arteriovenous fistulas, significant atherosclerotic stenosis disease of the neck or intracranial arteries (=70%), or malignant brain tumors. 8. Medical diagnosis (transient ischemic attack, myocardial infarction, atrial fibrillation, prosthetic heart valve, thrombosis after arteriovenous fistula or other surgery, unstable angina, etc.) requiring continuous use of aspirin, clopidogrel, or ticagrelor. 9. Thrombocytopenia (platelet count =1.5, and severe liver dysfunction at admission, defined as AST, ALT, AP (alkaline phosphatase), and GGT>2 times the upper limit of normal. 11. Creatinine clearance <30ml /min. 12. Serious comorbidities that could potentially confuse the study results include, but are not limited to, multiple sclerosis, dementia, major depression, a state of immunosuppression or during intensive immunosuppressive therapy, cancer that may lead to death within 1 year, multisystem organ failure, or any other condition that may lead to any degree of cognitive impairment. 13. Contraindications to antiplatelet aspirin: Allergy to the active ingredient aspirin, other salicylates or any other ingredient in the prescription; A history of asthma caused by salicylates or substances containing salicylates (particularly non-steroidal anti-inflammatory drugs); Patients with acute gastrointestinal ulcer; Patients with bleeding constitution; Patients with liver or renal failure; Patients with severe heart failure who do not receive appropriate treatment; In combination with methotrexate at a dose of 15 mg/ week or more; 14. Pregnancy status or positive HCG test. 15. The treating physician thought that the responsible aneurysm was not completely repaired and that the possibility of rebleeding in the near future was very high. 16. History of head trauma within 3 months. Any recent brain disease within 17.3 months, such as tumor, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc. 18. History of mental illness or seizures. 19. Lactating women. 20. Life expectancy before SAH onset is less than 1 year. 21. Participation in another randomized clinical trial may have confounded the assessment of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a modified Rankin Scale (mRS) score of 0 - 2 at 90 days after randomization.;Overall mortality at 90 days after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Extended Glasgow Prognostic Score at 90 Days After Randomization;Shift in modified Rankin Scale at 90 Days After Randomization (mRS 5 and 6 Combined).;Proportion of mRS Scores 0–3 at 90 Days After Randomization;Cognitive Function Score at 90 Days After Randomization;Extended Glasgow Outcome Score (eGOS) at 1 Year After Randomization;Shift in modified Rankin Scale at 1 Year After Randomization (mRS 5 and 6 Combined).;Proportion of patients with modified Rankin Scale (mRS) score 0–2 at 1 year after randomization;Proportion of mRS 0–3 at 1 Year After Randomization;Cognitive Function Score at 1 Year After Randomization;Changes in NIHSS score at discharge compared with baseline;In-hospital mortality;Incidence of symptomatic intracerebral hemorrhage;Incidence of any new type of intracranial hemorrhage; | — |
Countries
China
Contacts
Public ContactQiuhua Jiang
Ganzhou People's Hospital
Outcome results
None listed