CTRI/2023/11/060169RecruitingPhase 4
Comparison of phenytoin aand leveteracitam for prophylaxis of seizures in the early postoperative period in TBI patients-a pilot study
Hospital supplyfree of cost Sherikashmir institute of medical sciences1 site in 1 country30 target enrollmentStarted: November 30, 2023Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1)Time to first seizure
Study Overview
Brief Summary
Traumatic brain injury is one of the leading causes of death and disability through out the world .Occurance of seizures can worsen the outcome in these patients. Though TBI guidelines advocate the use of phenytoin for early onset seizures in TBI, there is emerging evidence that the use of the broad spectrum drugs as leveteracitam may be helpful in ameliorating the seizures in the early postoperative period .This pilot study is being done to compare phenytoin with levetiracetam for prophylaxis of seizures in TBI patients.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 95.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Pts 18yrs or above 2)Pts with diagnosis of TBI 3)GCS less than 8.
Exclusion Criteria
- •Pts with history of epilepsy or seizure disorder.
- •Pt with history of hypersensitivity or allergy to phenytoin or leviteracetam.
- •Pt with history of liver or kidney disease.
- •Pts who are pregnant or breast feeding.
- •Pts who don’t give consent.
Outcomes
Primary Outcomes
1)Time to first seizure
Time Frame: During 7 days
2)total seizures during 7 days
Time Frame: During 7 days
Secondary Outcomes
- No. of days of icu stay.(No. of days of hospital stay)
Investigators
Study Sites (1)
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