Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

Traumatic Brain Injury Clinical Trial

— Keppra  

Official title:

Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618436
• Other study ID #: 06-4-6-7
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2008
• Last updated: March 7, 2014
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To show that the use of intravenous levetiracetam(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.

Description:

To show that the use of intravenous levetiracetam(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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with traumatic brain injury

• Glasgow Coma Score (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 mm Hg

• At least one reactive pupil

• A negative pregnancy test in females

• Age at least 18 years

• Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR

• Subjects with subarachnoid hemorrhage (SAH)

• SAH documented by CT scan

• Hunt-Hess grade 3-5, inclusive

• Hemodynamically stable with a systolic BP> 90 mm Hg

• At least one reactive pupil

• A negative pregnancy test in females

• Age of at least 18 years

• Signed informed consent and HIPAA authorization for research form

Exclusion Criteria for enrollment

• 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

• Positive pregnancy test in females

• Age less than 18 years of age

• Known hypersensitivity to any anticonvulsant

• An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.

• Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).

• Inability to obtain signed informed consent or HIPAA authorization for research.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hemorrhage
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

Drug:
• Levetiracetam
Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days.
• Phenytoin
The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, then started on maintenance dose of 5mg/kg/day, rounded to nearest 100mg dose, IV, q 12h for seven days.

Locations

Country	Name	City	State
United States	University of Cincinnati Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Mayfield Clinic & Spine Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Incidence	This was the number of patients in each group who demonstrated seizure activity during the course of the study	Duration of study, up to 6 months after the injury	No
Secondary	Extended Glasgow Outcome Score	This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.	at discharge; 3 and 6 months following injury	No
Secondary	Disability Rating Scale (DRS)	The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.	Discharge; 3 and 6 months following injury	No
Secondary	Incidence of Adverse Events		discharge; 3 and 6 months following injury	Yes