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

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. Identifier: NCT03054285
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : August 6, 2019
Information provided by (Responsible Party):
Richard Gonzalez, 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.

Condition or disease Intervention/treatment Phase
Seizures Traumatic Brain Injury Drug: Levetiracetam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
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?
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03054285

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Contact: Richard P Gonzalez, MD 708-327-2072
Contact: Michael Anstadt, MD 708-327.2072

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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Richard Gonzalez, MD    708-327-2072   
Contact: Michael Anstadt, MD    708-327-2706   
Sponsors and Collaborators
Loyola University
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Principal Investigator: Richard Gonzalez, MD Loyola University

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Responsible Party: Richard Gonzalez, Professor, Loyola University Identifier: NCT03054285    
Other Study ID Numbers: 209136
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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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:
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurologic Manifestations
Signs and Symptoms
Nootropic Agents