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
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Vasopressin Versus Catecholamines for Cerebral Perfusion Pressure Control in Brain Injured Trauma PatientsTraumatic Brain InjuryNCT00795366University of Miami96
已完成
4 期
Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early RecoveryBrain InjuriesNCT00035139National Center for Research Resources (NCRR)
Unknown
不适用
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP MonitoringBrain Electrical Impedance;Non-invasive Intracranial PressureNCT02027857Xijing Hospital60
已完成
4 期
Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm PhenomenonTraumatic Brain InjuryNCT03401515Ain Shams University60
撤回
3 期
Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI)TBIMajor DepressionNCT02845349Johns Hopkins University
