Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
Primary Purpose
Seizures, Traumatic Brain Injury
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Seizures focused on measuring Seizures, Traumatic Brain Injury, Prophylaxis, Levetiracetam
Eligibility Criteria
Inclusion Criteria:
- Patients who have suffered intracranial injury identified by CT Scan
Exclusion Criteria:
- Age less than 18
- Pregnant patients
- Death in ED
- Seizure history or use of antiepileptic medication prior to admission
- Contraindication to study drug
- Any post-injury seizures prior to randomization
Sites / Locations
- Loyola University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No seizure prophylaxis
Seizure Prophylaxis
Arm Description
Participants randomized to this arm will not receive anti-seizure prophylaxis
Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.
Outcomes
Primary Outcome Measures
Seizures (count of seizures)
For all patients, the count of seizures will be recorded and compared between the two arms
Secondary Outcome Measures
Mortality
For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03054285
Brief Title
Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
Official Title
Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. A secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.
Detailed Description
The efficacy of anti-seizure prophylaxis in head injury patients remains controversial. Current recommendations for the use of anti-seizure prophylaxis are based upon a single institution study that has not been reproduced with other studies contradicting their conclusions. The proposed study will be a randomized prospective study at Loyola University Medical Center to assess the efficacy of anti-seizure prophylaxis in patients who have suffered traumatic brain injury (TBI). Patients with suspected TBI will undergo computed tomographic (CT) scan of the head. Following identification of TBI on CT scan, patients will be randomized to one of two study groups. Patients will be randomized to receive a seven-day course of anti-seizure prophylaxis with levetiracetam (UCB Pharma Inc.; Keppra) or randomized to a study group that will not receive anti-seizure prophylaxis. Patients will be consented prior to entry in the study. Patients will be followed for a total of seven days post injury for clinical signs of seizure activity. Additionally, patients will be assessed at one month post injury for clinical signs of seizure activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Traumatic Brain Injury
Keywords
Seizures, Traumatic Brain Injury, Prophylaxis, Levetiracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The intervention study model is a randomized block design using a 1:1 allocation scheme
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No seizure prophylaxis
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will not receive anti-seizure prophylaxis
Arm Title
Seizure Prophylaxis
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury
Primary Outcome Measure Information:
Title
Seizures (count of seizures)
Description
For all patients, the count of seizures will be recorded and compared between the two arms
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have suffered intracranial injury identified by CT Scan
Exclusion Criteria:
Age less than 18
Pregnant patients
Death in ED
Seizure history or use of antiepileptic medication prior to admission
Contraindication to study drug
Any post-injury seizures prior to randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard P Gonzalez, MD
Phone
708-327-2072
Email
richard.gonzalez@lumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Anstadt, MD
Phone
708-327.2072
Email
manstadt@lumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gonzalez, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Gonzalez, MD
Phone
708-327-2072
Email
richard.gonzalez@lumc.edu
First Name & Middle Initial & Last Name & Degree
Michael Anstadt, MD
Phone
708-327-2706
Email
manstadt@lumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.
Citations:
PubMed Identifier
24554454
Citation
Pitkanen A, Immonen R. Epilepsy related to traumatic brain injury. Neurotherapeutics. 2014 Apr;11(2):286-96. doi: 10.1007/s13311-014-0260-7.
Results Reference
background
PubMed Identifier
24249751
Citation
Torbic H, Forni AA, Anger KE, Degrado JR, Greenwood BC. Antiepileptics for seizure prophylaxis after traumatic brain injury. Am J Health Syst Pharm. 2013 Dec 1;70(23):2064, 2067. doi: 10.2146/ajhp130439. No abstract available.
Results Reference
background
PubMed Identifier
25712562
Citation
Cranley MR, Craner M, McGilloway E. Antiepileptic prophylaxis following severe traumatic brain injury within a military cohort. J R Army Med Corps. 2016 Apr;162(2):109-14. doi: 10.1136/jramc-2014-000392. Epub 2015 Feb 24.
Results Reference
background
PubMed Identifier
2115976
Citation
Temkin NR, Dikmen SS, Wilensky AJ, Keihm J, Chabal S, Winn HR. A randomized, double-blind study of phenytoin for the prevention of post-traumatic seizures. N Engl J Med. 1990 Aug 23;323(8):497-502. doi: 10.1056/NEJM199008233230801.
Results Reference
background
PubMed Identifier
6409521
Citation
Young B, Rapp RP, Norton JA, Haack D, Walsh JW. Failure of prophylactically administered phenytoin to prevent post-traumatic seizures in children. Childs Brain. 1983;10(3):185-92. doi: 10.1159/000120113.
Results Reference
background
PubMed Identifier
24368357
Citation
Bhullar IS, Johnson D, Paul JP, Kerwin AJ, Tepas JJ 3rd, Frykberg ER. More harm than good: antiseizure prophylaxis after traumatic brain injury does not decrease seizure rates but may inhibit functional recovery. J Trauma Acute Care Surg. 2014 Jan;76(1):54-60; discussion 60-1. doi: 10.1097/TA.0b013e3182aafd15.
Results Reference
background
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Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
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