Recruiting

Anti-Seizure Prophylaxis

Sponsor:

Loyola University

Code:

NCT03054285

Conditions

Seizures

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Levetiracetam

Study Details

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.

Conditions

Seizures

Traumatic Brain Injury

Study ID

NCT03054285

Start date

Jul 1, 2017

Status verified date

Aug, 2019

Completion date

Apr 1, 2021

Anticipated

Primary completion date

Apr 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

2300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No seizure prophylaxis

Participants randomized to this arm will not receive anti-seizure prophylaxis

experimental: Seizure Prophylaxis

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

Interventions

Levetiracetam

Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury

Primary outcome measure

  • Seizures (count of seizures) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Richard P Gonzalez, MD

708-327-2072richard.gonzalez@lumc.edu

Michael Anstadt, MD

708-327.2072manstadt@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Richard Gonzalez, MD

708-327-2072richard.gonzalez@lumc.edu

Michael Anstadt, MD

708-327-2706manstadt@lumc.edu

More Information

Sponsor

Loyola University

Last update posted

Aug 6, 2019

Last verified

Aug, 2019

Keywords

  • Seizures
  • Traumatic Brain Injury
  • Prophylaxis
  • Levetiracetam

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2019-08-06.