Maywood, Illinois 60153

  • Traumatic Brain Injury

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03054285


Primary Contact:

Principal Investigator
Richard Gonzalez, MD
Loyola University

Richard P Gonzalez, MD
Phone: 708-327-2072
Email: richard.gonzalez@lumc.edu


Backup Contact:

Email: manstadt@lumc.edu
Michael Anstadt, MD
Phone: 708-327.2072


Location Contact:

Maywood, Illinois 60153
United States

Richard Gonzalez, MD
Phone: 708-327-2072
Email: richard.gonzalez@lumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.