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临床试验/CTRI/2023/11/060169
CTRI/2023/11/060169招募中4 期

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 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月30日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
1)Time to first seizure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

1)Time to first seizure

时间窗: During 7 days

2)total seizures during 7 days

时间窗: During 7 days

次要结局

  • No. of days of icu stay.(No. of days of hospital stay)

研究者

发起方
Hospital supplyfree of cost Sherikashmir institute of medical sciences
申办方类型
Government medical college

研究点 (1)

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