A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Not Applicable

Terminated

Brief Summary: Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.

Detailed Description: The goals are to compare IV LCM and IV fPHT for seizure prophylaxis in the neuro-critical care setting in terms of the following outcome measures:

1. The short- and long-term incidence of adverse events related to the anticonvulsant medication

2. The frequency of clinically-evident and sub-clinical seizures, as demonstrated by continuous EEG monitoring for the first three days and by clinical assessment for up to 6 months after initial admission.

3. Intermediate and long-term outcomes as measured by standard outcome measures including Extended Glasgow Outcome Scale, Disability Rating Scale, and Resource Utilization Questionnaire

Recruitment & Eligibility

Inclusion Criteria

Subject with traumatic brain injury admitted to the hospital less than 24 hours prior to randomization
GCS score 3-8 (inclusive) or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
Hemodynamically stable with a systolic BP > 90 mmHg
At least one reactive pupil
Age at least 18 years
Signed informed consent and HIPAA authorization for research form
Patients will not be excluded because of race, gender, educational status or occupation

Exclusion Criteria

No venous access
Spinal cord injury
History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
Hemodynamically unstable
Suspected anoxic events
Other peripheral trauma likely to result in liver failure
Age less than 18 years of age
Known hypersensitivity to any anticonvulsant
Any treatment, condition, or injury that contraindicates treatment with Lacosamide (LCM) or fos-phenytoin (fPHT)
Inability to obtain signed informed consent or HIPAA authorization for research

Arm && Interventions

Group	Intervention	Description
IV LCM (lacosamide)	lacosamide	Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.
IV fPHT (fos-phenytoin)	Fosphenytoin	Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	baseline to 7 days	The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Seizures	baseline to 72 hours	Number of seizures in the first 72 hours based on EEG recording

Locations (3): UC Health Medical Arts Building
🇺🇸
Cincinnati, Ohio, United States
UC Health University Pointe
🇺🇸
Cincinnati, Ohio, United States
University Hospital
🇺🇸
Cincinnati, Ohio, United States