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

This study is not yet open for participant recruitment.
Verified March 2017 by Richard Gonzalez, Loyola University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03054285
First Posted: February 15, 2017
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Gonzalez, Loyola University
  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.

Condition Intervention Phase
Seizures Traumatic Brain Injury Drug: Levetiracetam Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The intervention study model is a randomized block design using a 1:1 allocation scheme
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?

Resource links provided by NLM:


Further study details as provided by Richard Gonzalez, Loyola University:

Primary Outcome Measures:
  • Seizures (count of seizures) [ Time Frame: 30 days ]
    For all patients, the count of seizures will be recorded and compared between the two arms


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ]
    For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.


Estimated Enrollment: 2300
Anticipated Study Start Date: April 1, 2017
Estimated Study Completion Date: April 1, 2021
Estimated Primary Completion Date: April 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Levetiracetam
Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury
Other Name: Keppra

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054285


Contacts
Contact: Richard P Gonzalez, MD 708-327-2072 richard.gonzalez@lumc.edu
Contact: Michael Anstadt, MD 708-327.2072 manstadt@lumc.edu

Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Richard Gonzalez, MD Loyola University
  More Information

Publications:
Responsible Party: Richard Gonzalez, Director of Trauma, Critical Care, Burns and ACS, Loyola University
ClinicalTrials.gov Identifier: NCT03054285     History of Changes
Other Study ID Numbers: 209136
First Submitted: February 13, 2017
First Posted: February 15, 2017
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Richard Gonzalez, Loyola University:
Seizures
Traumatic Brain Injury
Prophylaxis
Levetiracetam

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs