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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03054285
Enrollment
2300
Registered
2017-02-15
Start date
2017-07-01
Completion date
2021-04-01
Last updated
2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizures, Traumatic Brain Injury

Keywords

Seizures, Traumatic Brain Injury, Prophylaxis, Levetiracetam

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.

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.

Interventions

DRUGLevetiracetam

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

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The intervention study model is a randomized block design using a 1:1 allocation scheme

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Seizures (count of seizures)30 daysFor all patients, the count of seizures will be recorded and compared between the two arms

Secondary

MeasureTime frameDescription
Mortality30 daysFor all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.

Countries

United States

Contacts

Primary ContactRichard P Gonzalez, MD
richard.gonzalez@lumc.edu708-327-2072
Backup ContactMichael Anstadt, MD
manstadt@lumc.edu708-327.2072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026