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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levetiracetam | Experimental | levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days |
|
| lacosamide | Experimental | lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug | levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Early Post-traumatic Seizure | Number of early post-traumatic seizures documented | Up to day 7 post injury |
| Measure | Description | Time Frame |
|---|---|---|
| Richmond Agitation-Sedation Scale Score Attainment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bailey Baswell, BS | Contact | 704-446-88221 | bailey.baswell@advocatehealth.org | |
| Rita Brintzenhoff, MD | Contact | 704-446-5756 | Rita.Brintzenhoff@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Rita Brintzenhoff, MD | Atrium Health Carolina Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| lacosamide | Drug | lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days |
|
|
| Hour 24, hour 48, day 7 and day 10 post first drug administration |
| Administration of Agitation Medications | Use of as needed or scheduled agitation medications | Hour 24, hour 48, day 7 and day 10 |
| Incidence of Late Post-traumatic Seizures | Number of late post-traumatic seizures | Day 8 post injury through day 30 |
| Intensive Care Unit Length of Stay | Number of days participant spent in Intensive Care Unit | Admission through day 30 |
| Number of Readmissions to Intensive Care Unit | Number of times patient is readmitted to the Intensive Care Unit | Admission through day 30 |
| Total Hospital Length of Stay | Number of days participant was admitted to the hospital | Admission through day 30 |
| Duration of Mechanical Ventilation | Length of time participant was on mechanical ventilation | Admission through day 30 |
| Total Cost of Hospitalization | Cost of hospitalization data will be obtained from Surgical Trauma Intensive Care Unit data mart from the Acute Care Surgery Department | Admission through day 30 |
| Number of In-hospital Mortalities | Number of participant mortalities while admitted to hospital | Admission through day 30 |
| Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management | Of participants who developed a posttraumatic seizure, number of patients who required operative neurosurgery interventions | Admission through day 30 |
| Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma | Of participants who developed a posttraumatic seizure, number of patients who had subdural hematomas | Admission through day 30 |
| Incidence of Agitation Medication Use - Non-intubated Patients | Incidence of agitation medication use (as-needed or scheduled) in non-intubated patients will be assessed via chart review | Admission through day 30 |
| Post-traumatic Seizure with Anti-Seizure Medication | Number of participants who received anti-seizure medication within four hours vs 5-24 hours from injury | Day 7 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |