Comparing different medicines for preventing fits/seizures /convulsions in accident patients

Phase 4

Recruiting

• Conditions: Unspecified intracranial injury,

• Registration Number: CTRI/2023/11/060169
• Lead Sponsor: Hospital supplyfree of cost Sherikashmir institute of medical sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Last Update Posted: 2024-08-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1)Pts 18yrs or above 2)Pts with diagnosis of TBI 3)GCS less than 8.

Exclusion Criteria

• 1)Pts with history of epilepsy or seizure disorder.
• 2)Pt with history of hypersensitivity or allergy to phenytoin or leviteracetam.
• 3)Pt with history of liver or kidney disease.
• 4)Pts who are pregnant or breast feeding.
• 5)Pts who don’t give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Time to first seizure	During 7 days
2)total seizures during 7 days	During 7 days

Secondary Outcome Measures

Name	Time	Method
No. of days of icu stay.	No. of days of hospital stay

Trial Locations

Locations (1)

Sheri Kashmir Institute of medical Sciences Soura; 🇮🇳 JAMMU, & KASHMIR, India

Sheri Kashmir Institute of medical Sciences Soura

🇮🇳JAMMU, & KASHMIR, India

Dr Zulfiqar Ali

Principal investigator

9419086761

zulfiqaraliiii@yahoo.com