Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?

NCT03054285 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 209136
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Seizures; Traumatic Brain Injury

Keywords

Seizures; Traumatic Brain Injury; Prophylaxis; Levetiracetam

Outcome Measures

Primary Outcomes (1)

• Seizures (count of seizures)

  For all patients, the count of seizures will be recorded and compared between the two arms

  30 days

Secondary Outcomes (1)

• Mortality

  30 days

Study Arms (2)

No seizure prophylaxis

NO INTERVENTION

Participants randomized to this arm will not receive anti-seizure prophylaxis

Seizure Prophylaxis

EXPERIMENTAL

Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury

Also known as: Keppra

Seizure Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have suffered intracranial injury identified by CT Scan

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (6)

• Pitkanen A, Immonen R. Epilepsy related to traumatic brain injury. Neurotherapeutics. 2014 Apr;11(2):286-96. doi: 10.1007/s13311-014-0260-7.

  PMID: 24554454 BACKGROUND

• 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.

  PMID: 24249751 BACKGROUND

• 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.

  PMID: 25712562 BACKGROUND

• 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.

  PMID: 2115976 BACKGROUND

• 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.

  PMID: 6409521 BACKGROUND

• 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.

  PMID: 24368357 BACKGROUND

MeSH Terms

Conditions

Seizures; Brain Injuries, Traumatic

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard Gonzalez, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard P Gonzalez, MD

CONTACT

708-327-2072; richard.gonzalez@lumc.edu

Michael Anstadt, MD

CONTACT

708-327.2072; manstadt@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The intervention study model is a randomized block design using a 1:1 allocation scheme

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: July 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)