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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Seizures, Traumatic Brain Injury

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention study model is a randomized block design using a 1:1 allocation scheme
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No seizure prophylaxis<br>Participants randomized to this arm will not receive anti-seizure prophylaxis | |
| Experimental: Seizure Prophylaxis<br>Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury. | Drug: Levetiracetam<br>* Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury<br>* Other names: Keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizures (count of seizures) | For all patients, the count of seizures will be recorded and compared between the two arms | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seizures, Traumatic Brain Injury, Prophylaxis, Levetiracetam