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Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)

RecruitingPhase 4Ages 18 Years - 70 YearsAllAll India Institute of Medical Sciences, Jodhpur
NCT07072624 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients of severe blunt TBI with GCS score less than 10. 2. Patients with GCS of more than 10 in the presence of computed tomographic imaging findings consistent with brain injury: subarachnoid hemorrhage \[SAH\], subdural hematoma \[SDH\], epidural hematoma \[EDH\], intracerebral hemorrhage \[ICH\], or diffuse axonal injury \[DAI\], depressed skull fracture. 3. Patients with penetrating injury. Exclusion Criteria: 1. Females of childbearing age with urine pregnancy test positive. 2. Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission, 3. Prehospital use of anticonvulsants 4. Development of seizures before enrolment.
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What it tests

  • Phenytoin
  • Levetiracetam
  • Placebo
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Where

3 sites
Postgraduate Institute of Medical Education & Research
Chandigarh, India
AIIMS Jodhpur
Jodhpur, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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