| February 8, 2008 |
| February 19, 2008 |
| August 2007 |
| August 2009 (final data collection date for primary outcome measure) |
| Seizure frequency [ Time Frame: Discharge, 3 and 6 months after injury ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00618436 on ClinicalTrials.gov Archive Site |
- Extended GOSE [ Time Frame: at discharge; 3 and 6 months following injury ] [ Designated as safety issue: No ]
- Disability Rating Scale [ Time Frame: Discharge; 3 and 6 months following injury ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: discharge; 3 and 6 months following injury ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Assess the Safety and Efficacy of a Seizure Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients |
| Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit |
To show that the use of intravenous levitiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity. |
To show that the use of intravenous levitiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
- Traumatic Brain Injury
- Subarachnoid Hemorrhage
|
- Drug: Levetiracetam
- Drug: Phenytoin
|
- Active Comparator: Group 1-treatment with Levetiracetam
- Active Comparator: Group 2-treatment with Phenytoin
|
| |
| |
| Recruiting |
| 104 |
| March 2010 |
| August 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Subjects with traumatic brain injury:
- 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 >90mmHg
- At least one reactive pupil
- A negative pregnancy test in females
- Age at least 18 years
- Signed informed consent and HIPAA authorization for research form OR Subjects with subarachnoid hemorrhage
- SAH documented by CT scan
- Hunt-Hess grade 3-5, inclusive
- Hemodynamically stable with a systolic BP> 90mmHg
- At least one reactive pupil
- A negative pregnany test in females
- Age of at least 18 years
- Signed informed consent and HIPAA authorization for research form
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00618436 |
| Lori Shutter, MD, Mayfield Clinic Inc |
| 06-4-6-7 |
| Mayfield Clinic & Spine Institute |
|
| Principal Investigator: |
Lori Shutter, MD |
Mayfield Clinic Inc |
|
|
| Mayfield Clinic & Spine Institute |
| February 2008 |
