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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03054285
• Other study ID #: 209136
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: April 1, 2021

Study information

• Verified date: August 2019
• Source: Loyola University
• Contact: Richard P Gonzalez, MD
• Phone: 708-327-2072
• Email: richard.gonzalez[@]lumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Seizures
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizures (count of seizures)	For all patients, the count of seizures will be recorded and compared between the two arms	30 days
Secondary	Mortality	For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.	30 days