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Seizure Prophylaxis following Intracerebral Hemorrhage study

A randomised, blinded, placebo-controlled trial of shor-term sodium valproate prophylaxis in patients with acute spontaneous supratentorial intracerebral hemorrhage

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PRC-11001294
Enrollment
Unknown
Registered
2011-04-05
Start date
2011-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Acute spontaneous supratentorial intracerebral hemorrhage

Interventions

Group B:conventional therapy+placebo
Group A:conventional therapy+oral sodium valproate 500mg daily for 7 days(temporary alternative therapy with 400mg by intravenous infusion in 250ml 0.9% normal saline)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >18 years of age; 2. Diagnosis of spontaneous supratentorial ICH identified by CT; 3. Admission within 72 hours from ictus; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. ICH secondary to trauma, tumor or infarct; 2. Early death (defined as death within 3 days of presentation); 3. Prior mRS>=3 or dementia; 4. Know seizure history on chronic AEDs; 5. Prior seizure from onset; 6. Elevated liver enzymes(three times normal); 7. Known allergy to sodium valproate; 8. Pregnant or lactating woman Pregnancy or current incarceration.

Design outcomes

Primary

MeasureTime frame
Seizure onset;

Secondary

MeasureTime frame
hematoma enlargement and midline shift;Gos and mRS score of 7 day, 3 and 6 month;

Countries

China

Contacts

Public ContactChao You, Ming Liu
youchaowestchina@163.com+86 28 85422905

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026