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Seizure prophylaxis following aneurysmal subarachnoid hemorrhage (SPSAH): a multicenter randomized placebo-controlled trial of short-term sodium valproate prophylaxis in patients with acute subarachnoid hemorrhage

Seizure prophylaxis following aneurysmal subarachnoid hemorrhage (SPASH): a multicenter randomized placebo-controlled trial of short-term sodium valproate prophylaxis in patients with acute subarachnoid hemorrhage

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050161
Enrollment
Unknown
Registered
2021-08-19
Start date
2021-08-20
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aneurysmal subarachnoid hemorrhage

Interventions

experimental group:intravenous sodium valproate

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Modified Rankin Scale (mRS) Score 0-1 before ictus; 3. Computed Tomography Angiography (CTA) or Digital Subtraction Angiography (DSA) confirmed diagnosis of aSAH caused by rupture of anterior circulation aneurysm; 4. Symptoms onset of aSAH occurred < 24 hours prior to presentation at the hospital; 5. Hunt-Hess grade <=3 on admission; 6. Surgical clipping is planned for treatment; 7. Patient is willing and able to accept long-term study follow-up; 8. Patient or their Legally Authorized Representative (LAR) has provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Concurrent non-ruptured aneurysm on the same admission; 2. SAH secondary to rupture of traumatic or infected aneurysm; 3. Prior anticonvulsant therapy or epilepsy; 4. Seizure before enrollment; 5. Use of carbapenem antibiotics within 7 days before enrollment; 6. History of coagulopathy; 7. Concurrent significant intracranial pathology, including but not limited to Moyamoya disease, arteriovenous malformation, arteriovenous fistula, or malignant brain tumor; 8. Serious co-morbidities, including but not limited to severe major depression, cancer (likely to cause death in 2 years), multi-system organ failure; 9. History of previous ruptured cerebral aneurysm; 10. Liver dysfunction (clinical laboratory markers for liver function 3 times greater than normal or cirrhosis), with acute or chronic hepatitis, history or family history of serious hepatitis (especially drug-induced hepatitis); 11. Known allergy to sodium valproate; 12. Pregnant woman; 13. Patients and/or LAR refuse treatment; 14. Enrollment in another research study that would conflict with this study; 15. Any other reasons that the investigator considers the patient is inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
seizure;

Secondary

MeasureTime frame
aSAH-related complications;modified Rankin Score;MoCA Score;all-cause death;good outcome (mRS 0-2);

Countries

China

Contacts

Public ContactHu Xin

Department of Neurosurgery, West China Hospital, Sichuan University

huxingxxy@gmail.com+86 13551277119

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026