Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Recruiting · NCT07072624 · Interventional (participants receive a specific treatment) · Lead sponsor: All India Institute of Medical Sciences, Jodhpur
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 provide high-quality evidence in PTS management and will establish the role of prophylactic anti-epileptics in PTS. This study also opens the plethora of undesignated roles of genetic polymorphism in the efficacy and safety of levetiracetam and phenytoin in traumatic brain injury patients.
Who can take part
Inclusion criteria
- Patients of severe blunt TBI with GCS score less than 10.
- 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.
- Patients with penetrating injury.
Exclusion criteria
- Females of childbearing age with urine pregnancy test positive.
- Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission,
- Prehospital use of anticonvulsants
- Development of seizures before enrolment.
Where it is running
3 locations listed.
- Postgraduate Institute of Medical Education & Research - Chandigarh, Punjab, India
- AIIMS Jodhpur - Jodhpur, Rajasthan, India
- Sanjay Gandhi Postgraduate Institute of Medical Sciences - Lucknow, Uttar Pradesh, India