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

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to prevent seizures that can happen soon after a serious head injury, known as a traumatic brain injury (TBI). Researchers want to find out if two different seizure-preventing medicines, phenytoin and levetiracetam, work better than no medicine (a placebo) in stopping these early seizures. They will also look at how a person’s genes might affect how well these medicines work and their safety. This is an important study because seizures after a brain injury can cause more problems, but doctors aren’t yet sure which medicine is best to prevent them.

People who might be eligible to join this study include adults who have had a severe head injury, especially those with certain signs of brain damage seen on scans or those with a low score on a test that measures how awake and aware they are (called the Glasgow Coma Scale). Women who are pregnant or people who already had seizures before joining won’t be able to participate. If someone joins, they will be randomly assigned to receive one of the two medicines or a placebo, and neither the patients nor the doctors will know which one they get until the study ends. The researchers will monitor participants to see if seizures occur, check their recovery progress, watch for side effects, and study the costs involved. This trial aims to provide clear answers to help doctors better protect people with brain injuries from early seizures.

Gender

ALL

Eligibility criteria

• 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.