A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Stopped early · Not applicable
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT01110187
- Run by
- University of Alabama at Birmingham
- People needed
- 11
- Starts
- 2010-05-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2014-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UC Health University Pointe — Cincinnati, Ohio, United States
- UC Health Medical Arts Building — Cincinnati, Ohio, United States
- University Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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