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

NCT ID: NCT03054285

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-04-01

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.

Conditions

Seizures; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No seizure prophylaxis

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Seizure Prophylaxis

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

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

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

Interventions

Levetiracetam

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

Intervention Type: DRUG

Other Intervention Names

Keppra

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Richard Gonzalez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Richard P Gonzalez, MD

Role: CONTACT

richard.gonzalez@lumc.edu

708-327-2072

Michael Anstadt, MD

Role: CONTACT

manstadt@lumc.edu

708-327.2072

Facility Contacts

Richard Gonzalez, MD

Role: primary

richard.gonzalez@lumc.edu

708-327-2072

Michael Anstadt, MD

Role: backup

manstadt@lumc.edu

708-327-2706

References

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

Reference Type: BACKGROUND

PMID: 24554454 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24249751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25712562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2115976 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6409521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24368357 (View on PubMed)

Other Identifiers

209136

Identifier Type: -

Identifier Source: org_study_id