Traumatic Brain Injury
Conditions
Keywords
Brain Injury, Post-Traumatic Seizures, Seizure Medication
Brief summary
The purpose of this study is to assess the incidence of early post-traumatic seizures. The study will also assess the benefit of lacosamide compared to levetiracetam in regards to agitation and behavioral adverse effects in patients with traumatic brain injury requiring seizure prophylaxis.
Detailed description
This is a prospective randomized controlled trial of patients with TBI requiring seizure prophylaxis to prevent early and late posttraumatic seizures. Patients will be identified and randomized as soon as possible, within 24 hours, from injury and started on seizure prophylaxis if they meet the predefined inclusion and exclusion criteria. Patients randomized to the levetiracetam group will receive levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days. Patients randomized to the lacosamide group will receive lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days.
Interventions
DRUGlevetiracetam
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
DRUGlacosamide
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Diagnosis of traumatic brain injury: severe, moderate, or mild with high-risk imaging features * Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury * Patients admitted into the trauma team service
Exclusion criteria
* Enrolled in another interventional drug study * Any active, witnessed, or unable to rule out seizure prior to prophylaxis initiation * Received antiseizure medication (ASM), for prophylaxis or treatment, prior to randomization * History of seizures * On anti-epileptic medications for seizures or indications other than seizures prior to admission * Documented history of alcohol withdrawal and experiencing alcohol withdrawal on admission with initiation of clinical institute withdrawal assessment scale revised (CIWA-Ar) or modified Minnesota Detoxification Scale (mMINDS) requiring treatment * Spinal cord injury (SCI), confirmed by radiographic imaging demonstrating cervical (C1 to C8) or thoracic-spine (T1 to T12) injuries consistent with spinal cord injury * History of bradycardia or permanent pacemaker or signs of bradycardia with HR \< 55 bpm for \> 5 min not on medications that cause bradycardia * End-stage renal disease (ESRD) * Death, withdrawal of life support or transfer to hospice within 24 hours * Pregnant or incarcerated * Baseline GCS \< 13 or unable to determine baseline GCS * Patient with a GCS of 15 or Legally Authorize Representative (LAR) unable to provide informed consent prior to randomization, or unable to read and understand English, Spanish, Vietnamese, Russian, Arabic, or French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Early Post-traumatic Seizure | Up to day 7 post injury | Number of early post-traumatic seizures documented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Richmond Agitation-Sedation Scale Score Attainment | Hour 24, hour 48, day 7 and day 10 post first drug administration | It will be noted if the participant attains their Richmond Agitation-Sedation Scale (RASS) score goal within the various time periods. Goal scores will vary per participant from -5 to +1, depending on individualized sedation goals. If participants are not maintained within their RASS goal and must receive as-needed or scheduled agitation medications to attain their RASS goal, they will be considered to have agitation. |
| Administration of Agitation Medications | Hour 24, hour 48, day 7 and day 10 | Use of as needed or scheduled agitation medications |
| Incidence of Late Post-traumatic Seizures | Day 8 post injury through day 30 | Number of late post-traumatic seizures |
| Intensive Care Unit Length of Stay | Admission through day 30 | Number of days participant spent in Intensive Care Unit |
| Number of Readmissions to Intensive Care Unit | Admission through day 30 | Number of times patient is readmitted to the Intensive Care Unit |
| Total Hospital Length of Stay | Admission through day 30 | Number of days participant was admitted to the hospital |
| Duration of Mechanical Ventilation | Admission through day 30 | Length of time participant was on mechanical ventilation |
| Total Cost of Hospitalization | Admission through day 30 | Cost of hospitalization data will be obtained from Surgical Trauma Intensive Care Unit data mart from the Acute Care Surgery Department |
| Number of In-hospital Mortalities | Admission through day 30 | Number of participant mortalities while admitted to hospital |
| Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management | Admission through day 30 | Of participants who developed a posttraumatic seizure, number of patients who required operative neurosurgery interventions |
| Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma | Admission through day 30 | Of participants who developed a posttraumatic seizure, number of patients who had subdural hematomas |
| Incidence of Agitation Medication Use - Non-intubated Patients | Admission through day 30 | Incidence of agitation medication use (as-needed or scheduled) in non-intubated patients will be assessed via chart review |
| Post-traumatic Seizure with Anti-Seizure Medication | Day 7 | Number of participants who received anti-seizure medication within four hours vs 5-24 hours from injury |
Countries
United States
Contacts
CONTACTBailey Baswell, BS
CONTACTRita Brintzenhoff, MD
PRINCIPAL_INVESTIGATORRita Brintzenhoff, MD
Atrium Health Carolina Medical Center
Outcome results
None listed