Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: levetiracetam, lacosamide.
- Кому может быть актуально
- Состояния в реестре: Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of Levetiracetam and Lacosamide
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат levetiracetam
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days - Препарат lacosamide
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
Первичные конечные точки
- Incidence of Early Post-traumatic Seizure [Срок оценки: Up to day 7 post injury]
Вторичные конечные точки (12)
- Richmond Agitation-Sedation Scale Score Attainment [Срок оценки: Hour 24, hour 48, day 7 and day 10 post first drug administration]
- Administration of Agitation Medications [Срок оценки: Hour 24, hour 48, day 7 and day 10]
- Incidence of Late Post-traumatic Seizures [Срок оценки: Day 8 post injury through day 30]
- Intensive Care Unit Length of Stay [Срок оценки: Admission through day 30]
- Number of Readmissions to Intensive Care Unit [Срок оценки: Admission through day 30]
- Total Hospital Length of Stay [Срок оценки: Admission through day 30]
- Duration of Mechanical Ventilation [Срок оценки: Admission through day 30]
- Total Cost of Hospitalization [Срок оценки: Admission through day 30]
- Number of In-hospital Mortalities [Срок оценки: Admission through day 30]
- Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management [Срок оценки: Admission through day 30]
- Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma [Срок оценки: Admission through day 30]
- Incidence of Agitation Medication Use - Non-intubated Patients [Срок оценки: Admission through day 30]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- Wake Forest University Health Sciences — Winston-Salem
Идентификаторы
NCT: NCT06866691 · IRB00123210