Clinical trial NCT03054285: Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
Official title: Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Seizures
Traumatic Brain Injury
Keywords: Seizures
Traumatic Brain Injury
Prophylaxis
Levetiracetam
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention study model is a randomized block design using a 1:1 allocation scheme
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Seizures (count of seizures)
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Richard Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitkanen A, Immonen R. Epilepsy related to traumatic brain injury. Neurotherapeutics. 2014 Apr;11(2):286-96. doi: 10.1007/s13311-014-0260-7.
citation: Torbic H, Forni AA, Anger KE, Degrado JR, Greenwood BC. Antiepileptics for seizure prophylaxis after traumatic brain injury. Am J Health Syst Pharm. 2013 Dec 1;70(23):2064, 2067. doi: 10.2146/ajhp130439. No abstract available.
citation: Cranley MR, Craner M, McGilloway E. Antiepileptic prophylaxis following severe traumatic brain injury within a military cohort. J R Army Med Corps. 2016 Apr;162(2):109-14. doi: 10.1136/jramc-2014-000392. Epub 2015 Feb 24.
citation: Temkin NR, Dikmen SS, Wilensky AJ, Keihm J, Chabal S, Winn HR. A randomized, double-blind study of phenytoin for the prevention of post-traumatic seizures. N Engl J Med. 1990 Aug 23;323(8):497-502. doi: 10.1056/NEJM199008233230801.
citation: Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent post-traumatic seizures in children. Childs Brain. 1983;10(3):185-92. doi: 10.1159/000120113.
citation: Bhullar IS, Johnson D, Paul JP, Kerwin AJ, Tepas JJ 3rd, Frykberg ER. More harm than good: antiseizure prophylaxis after traumatic brain injury does not decrease seizure rates but may inhibit functional recovery. J Trauma Acute Care Surg. 2014 Jan;76(1):54-60; discussion 60-1. doi: 10.1097/TA.0b013e3182aafd15.