Condition: Seizures · Traumatic Brain Injuries · Traumatic Brain Injury (TBI) Patients · Sponsor: All India Institute of Medical Sciences, Jodhpur
Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence. Novelty: Literature is scarce regarding the ideal management of early PTS in traumatic brain injury (TBI), a major public health problem. Further, no study has evaluated the effect of genetic polymorphism on seizure occurrence in traumatic brain injury. This Multicentric study will be the first of its kind, not only in India but also globally. Objectives: To evaluate the seizure incidence \& efficacy of the respective anti-epileptic drug in each treatment arm. Assessment of clinical \& functional outcomes, safety profile, and cost-effectiveness in each group. Effect of genetic polymorphisms on seizure incidence among study participants Methods: A Multicentric prospective randomized placebo-controlled double-blinded clinical trial is planned. After satisfying eligibility criteria and informed consent, TBI patients will be randomly allocated into three arms 'phenytoin arm', 'levetiracetam arm', and 'placebo'. Drug polymorphism will be analyzed in all the patients using quantitative real-time PCR. Expected outcome: This study will provi…
This description comes directly from the study's public registry record.
Dr Jaskaran Singh Gosal Associate Professor, MCh Neurosurgery · 91 6283475891 · jhsgosal_87@hotmail.com
Dr Shoban Babu Varthya Associate Professor, MD Pharmacology · 91 8437726777 · drshobanpgimer@gmail.com
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| Postgraduate Institute of Medical Education & Research | Chandigarh, Punjab, India | Recruiting |
| AIIMS Jodhpur | Jodhpur, Rajasthan, India | Recruiting |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow, Uttar Pradesh, India | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07072624