Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/8/2018 |
| Start Date: | July 1, 2017 |
| End Date: | April 1, 2021 |
| Contact: | Richard P Gonzalez, MD |
| Email: | richard.gonzalez@lumc.edu |
| Phone: | 708-327-2072 |
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.
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.
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.
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.
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
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-2072
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