Health Condition 1: I676- Nonpyogenic thrombosis of intracranial venous system
Conditions
Interventions
Intervention1: Levetiracetam: All participants in the study will receive standard of care. In the secondary prevention arm, all patients will receive levetiracetam 500 mg twice a day for 2 weeks befor
Sponsors
DHRICMR
Eligibility
Inclusion criteria
Inclusion criteria: Primary Prevention Arm 1. Adult patients (age > 18 years) presenting with intracranial venous sinus thrombosis proven by CT/MRI brain and CT/MR Venography 2. Confirmation of diagnosis to randomisation within 14 days 3. No seizures at presentation Secondary Prevention Arm 1. Adult patients (age > 18 years) presenting with intracranial venous sinus thrombosis proven by CT/MRI brain and CT/MR Venography 2. Confirmation of diagnosis to randomisation within 14 days 3. Early post stroke seizures (
Exclusion criteria
Exclusion criteria: Primary Prevention Arm 1. Previous history of epilepsy or treatment with an AED 2. Seizure or status epilepticus at onset of stroke or prior to recruitment 3. Known allergy to Levetiracetam 4. Pregnant women 5. Chronic renal failure Secondary Prevention Arm 1. Previous history of epilepsy or treatment with an AED 2. Status epilepticus at onset of stroke or prior to recruitment 3. Known allergy to Levetiracetam 4. Pregnant women 5. Chronic renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who developed first clinical seizureTimepoint: 1 YEAR | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who developed status epilepticusTimepoint: 1 YEAR;Time from CVT to occurrence of a seizureTimepoint: 1 year;occurrence of seizure within 7 days of randomization (early epileptic seizures)Timepoint: 1 week;Occurrence of seizure after 7 days of randomization (late epileptic seizure)Timepoint: 1 year;Modified Rankin scaleTimepoint: 3 months;Occurrence of side effects of the medicationTimepoint: 1 year;complications (pneumonia, urinary tract infections, dyselectrolemia, midline shift)Timepoint: 1 YEAR;mortalityTimepoint: 3 months;Duration of hospital stayTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactVishnu V Y
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed