Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?

Phase 4

• Conditions: Seizures; Traumatic Brain Injury
• Interventions: Drug: Levetiracetam

• Registration Number: NCT03054285
• Lead Sponsor: Loyola University

Brief Summary

The primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. A secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.

Detailed Description

The efficacy of anti-seizure prophylaxis in head injury patients remains controversial. Current recommendations for the use of anti-seizure prophylaxis are based upon a single institution study that has not been reproduced with other studies contradicting their conclusions. The proposed study will be a randomized prospective study at Loyola University Medical Center to assess the efficacy of anti-seizure prophylaxis in patients who have suffered traumatic brain injury (TBI). Patients with suspected TBI will undergo computed tomographic (CT) scan of the head. Following identification of TBI on CT scan, patients will be randomized to one of two study groups. Patients will be randomized to receive a seven-day course of anti-seizure prophylaxis with levetiracetam (UCB Pharma Inc.; Keppra) or randomized to a study group that will not receive anti-seizure prophylaxis. Patients will be consented prior to entry in the study. Patients will be followed for a total of seven days post injury for clinical signs of seizure activity. Additionally, patients will be assessed at one month post injury for clinical signs of seizure activity.

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-15
• Study Start: 2017-07-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06
• Primary Completion: 2020-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

• Patients who have suffered intracranial injury identified by CT Scan

Exclusion Criteria

• Age less than 18
• Pregnant patients
• Death in ED
• Seizure history or use of antiepileptic medication prior to admission
• Contraindication to study drug
• Any post-injury seizures prior to randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seizure Prophylaxis	Levetiracetam	Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.

Primary Outcome Measures

Name	Time	Method
Seizures (count of seizures)	30 days	For all patients, the count of seizures will be recorded and compared between the two arms

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days	For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States