Domain Description
Objective
To evaluate whether the use of anticonvulsants improves long-term neurologic functional outcomes in critically ill patients with TBI.
Population
Adult patients admitted to the ICU following an acute moderate or severe TBI.
Primary Endpoint
Glasgow Outcome Scale extended (GOSe) at 6 months.
Secondary Endpoints
At day 7:
- Early seizure events (≤ day 7)
Hospital discharge
- All-cause mortality
At day 28
- ICU-free days
- Organ support free days
- Expected ICU events
- Serious adverse events (SAE)
At 6 months
- Quality of life (EQ-5D-5L)
- Cognition T-Montréal Cognitive Assessment test [T-MoCA])
- Depression (PHQ-9)
- All-cause mortality
- Late seizure events (> day 7)
Eligibility criteria
- Adult patients (≥ 18 years old)
- Acute moderate or severe acute TBI (GCS ≤12)
- No contraindication to anticonvulsants
- Not on anticonvulsants for seizure disorder prior to hospital admission
- No indication for anticonvulsants (early seizure requiring anticonvulsants)
- No more than 72 hours have elapsed since ICU admission
- No decision to withdraw life-sustaining therapies has been made
Interventions
Participants will be randomized to receive either anticonvulsivants or standard care during their ICU stay. The intervention will be administered from the time of randomization until ICU discharge, death, or a decision to withdraw life-sustaining therapies. Continuation of the intervention beyond ICU discharge will be left to the discretion of the medical team and be captured in our data collection.
Target Sample Size
Adapted based on pre-determined criteria defining superiority and futility.