Traumatic Brain InjuryNCT04836481
A Pharmacokinetic Analysis of Levetiracetam Prophylaxis in Critically Ill Patients With Severe Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University of Cincinnati at 1 site in United States.
Trial summary
This study aims is to describe the pharmacokinetic properties of levetiracetam through measurement of serum concentrations in critically ill, severe traumatic brain injury patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Serum Sample Collection
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study will be patients with severe traumatic brain injury, defined as a post-resuscitation GCS 3-8 with or without CT abnormalities who are receiving intravenous levetiracetam 1000 mg every 8 or every 12 hours for seizure prophylaxis.
Who may be able to join
- Admitted to the neurosurgical intensive care unit or surgical intensive care unit following severe traumatic brain injury (post-resuscitation GCS 3-8 with or without CT abnormalities)
- Receiving intravenous levetiracetam for seizure prophylaxis at a dose of 1000 mg every 12 hours or 1000 mg every 8 hours at time of enrollment
Who cannot join
- Known history of epilepsy or seizure disorder
- Taking antiseizure medication prior to admission
- Taking medication with known effect on levetiracetam pharmacokinetics including carbamazepine, phenytoin, oxcarbazepine, mefloquine, methotrexate, mianserin, or orlistat
- Weight < 50 kg
- Anticipated survival <72 hours from injury, as deemed by the primary neurosurgical provider
- Acute Kidney Injury (Scr rise > 0.3 mg/dL from baseline) or creatinine clearance <50 mL/min at time of enrollment
- Prisoners
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
This study aims is to describe the pharmacokinetic properties of levetiracetam through measurement of serum concentrations in critically ill, severe traumatic brain injury patients.
Read the detailed description
Levetiracetam (LEV) is widely used for the prevention and treatment of seizures given its favorable pharmacokinetic profile. A strong correlation between serum concentrations and clinical efficacy has yet to be established; however, a target of 6-20 g/mL is recommended. Limited evidence exists supporting an optimal dosing strategy to achieve these target concentrations in neurocritically ill patients. Previous pharmacokinetic models suggest LEV 1000 mg every 8 hours achieves the highest proportion of therapeutic serum concentrations, but this dosing strategy has not been clinically studied in neurocritically ill patients. Additionally, only one phase two study has evaluated LEV pharmacokinetics in severe traumatic brain injury (TBI).
The aim of this study is to describe the pharmacokinetic properties of LEV through measurement of serum concentrations in critically ill, severe TBI patients. Secondarily, this study aims to develop a population pharmacokinetic model aimed at characterizing LEV dose optimization in severe TBI. An exploratory aim is to evaluate LEV pharmacodynamics in severe TBI patients through evaluation of physiologic, electrophysiologic and biochemical changes using multimodal monitoring or surface electroencephalogram (EEG), as available. A subgroup analysis will evaluate LEV pharmacokinetics in severe TBI patients with augmented renal clearance (ARC).
This prospective, single-center pharmacokinetic and pharmacodynamic study will include critically ill patients receiving intravenous LEV for seizure prophylaxis following severe TBI. Patients with severe TBI qualifying for multimodal monitoring will receive LEV 1000 mg every 8 hours (LEV8) per institutional practice. All other severe TBI patients will receive LEV 1000 mg every 12 hours (LEV12) according to institution practice. Patients with renal dysfunction (creatinine clearance < 50 mL/min) will be excluded. All patients will have five serum samples collected following the sixth or greater consecutive dose. Patients receiving LEV8 will have samples collected at 0.5, 1, 4, 6, and 8 hours. Patients receiving LEV12 will have samples collected at 0.5, 1, 4, 8, and 12 hours. Serum concentrations will be analyzed with pharmacokinetic modeling and Monte Carlo simulations. LEV pharmacodynamics will be evaluated in patients receiving multimodal monitoring or surface EEG, as available. Analysis of ARC will include patients with Augmented Renal Clearance in Trauma Intensive Care (ARTIC) score >6 during sampling.
- Conditions
- Traumatic Brain Injury
- Being tested
- Serum Sample Collection
- Keywords
- Levetiracetam, Seizure Prophylaxis, Pharmacokinetic
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Sample CollectionOther
Each patient will have 5 serum samples collected for analysis after a minimum six consecutive doses. Patients receiving LEV8 will have sampled collected at hours 0.5, 1, 4, 6, and 8. Patients receiving LEV12 will have sampled collected at hours 0.5, 1, 4, 8, and 12.
| Study group | Role | What they receive |
|---|---|---|
| LEV8 | Levetiracetam 1000 mg every 8 hours Receives: Other: Serum Sample Collection | |
| LEV12 | Levetiracetam 1000 mg every 12 hours Receives: Other: Serum Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Levetiracetam Concentration 1
Serum levetiracetam concentration collected at 0.5 hours after target dose for sampling
Measured: Hour 0.5
Serum Levetiracetam Concentration 2
Serum levetiracetam concentration collected at hour 1 after target dose for sampling
Measured: Hour 1
Serum Levetiracetam Concentration 3
Serum levetiracetam concentration collected at hour 4 after target dose for sampling
Measured: Hour 4
Serum Levetiracetam Concentration 4
Serum levetiracetam concentration collected at hour 6 (patients receiving every 8 hour levetiracetam) or hour 8 (patients receiving every 12 hour levetiracetam)
Measured: Hour 6-8
Serum Levetiracetam Concentration 5
Serum levetiracetam concentration collected at hour 8 (patients receiving every 8 hour levetiracetam) or hour 12 (patients receiving every 12 hour levetiracetam)
Measured: Hour 8-12
Secondary outcomes (10)
Intracranial Pressure
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Perfusion Pressure
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Pressure Reactivity Index
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Blood Flow
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Microdialysis Glucose Concentration
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Microdialysis Pyruvate Concentration
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Microdialysis Lactate Concentration
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Microdialysis Glutamate Concentration
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
Cerebral Microdialysis Glycerol Concentration
Collected at baseline and at each time of serum sample collection for pharmacodynamic analysis
Measured: Baseline to Day 7
ARTIC Score
Calculated ARTIC score
Measured: Hour 0.5 (Collected at time of first serum sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jan 2021
- Primary completion1 May 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Responsible party
- Principal investigator, Sarah Schuman Harlan, University of Cincinnati
- Investigators
- Sarah Schuman Harlan, PharmD, Principal investigator, University of CincinnatiShaun Keegan, PharmD, Principal investigator, University of CincinnatiCarolyn Philpott, PharmD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836481
- Sponsor's protocol ID
- 2020-0744
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.
PubMed 30723936Rowe AS, Goodwin H, Brophy GM, Bushwitz J, Castle A, Deen D, Johnson D, Lesch C, Liang N, Potter E, Roels C, Samaan K, Rhoney DH; Neurocritical Care Society Pharmacy Section. Seizure prophylaxis in neurocritical care: a review of evidence-based support. Pharmacotherapy. 2014;34(4):396-409. doi: 10.1002/phar.1374. Epub 2013 Nov 26.
PubMed 24277723Barletta JF, Mangram AJ, Byrne M, Sucher JF, Hollingworth AK, Ali-Osman FR, Shirah GR, Haley M, Dzandu JK. Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system. J Trauma Acute Care Surg. 2017 Apr;82(4):665-671. doi: 10.1097/TA.0000000000001387.
PubMed 28129261Zangbar B, Khalil M, Gruessner A, Joseph B, Friese R, Kulvatunyou N, Wynne J, Latifi R, Rhee P, O'Keeffe T. Levetiracetam Prophylaxis for Post-traumatic Brain Injury Seizures is Ineffective: A Propensity Score Analysis. World J Surg. 2016 Nov;40(11):2667-2672. doi: 10.1007/s00268-016-3606-y.
PubMed 27307089Gabriel WM, Rowe AS. Long-term comparison of GOS-E scores in patients treated with phenytoin or levetiracetam for posttraumatic seizure prophylaxis after traumatic brain injury. Ann Pharmacother. 2014 Nov;48(11):1440-4. doi: 10.1177/1060028014549013. Epub 2014 Aug 28.
PubMed 25169249Inaba K, Menaker J, Branco BC, Gooch J, Okoye OT, Herrold J, Scalea TM, Dubose J, Demetriades D. A prospective multicenter comparison of levetiracetam versus phenytoin for early posttraumatic seizure prophylaxis. J Trauma Acute Care Surg. 2013 Mar;74(3):766-71; discussion 771-3. doi: 10.1097/TA.0b013e3182826e84.
PubMed 23425733Jones KE, Puccio AM, Harshman KJ, Falcione B, Benedict N, Jankowitz BT, Stippler M, Fischer M, Sauber-Schatz EK, Fabio A, Darby JM, Okonkwo DO. Levetiracetam versus phenytoin for seizure prophylaxis in severe traumatic brain injury. Neurosurg Focus. 2008 Oct;25(4):E3. doi: 10.3171/FOC.2008.25.10.E3.
PubMed 18828701Szaflarski JP, Sangha KS, Lindsell CJ, Shutter LA. Prospective, randomized, single-blinded comparative trial of intravenous levetiracetam versus phenytoin for seizure prophylaxis. Neurocrit Care. 2010 Apr;12(2):165-72. doi: 10.1007/s12028-009-9304-y.
PubMed 19898966Ramael S, Daoust A, Otoul C, Toublanc N, Troenaru M, Lu ZS, Stockis A. Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study. Epilepsia. 2006 Jul;47(7):1128-35. doi: 10.1111/j.1528-1167.2006.00586.x.
PubMed 16886975Steinhoff BJ, Staack AM. Levetiracetam and brivaracetam: a review of evidence from clinical trials and clinical experience. Ther Adv Neurol Disord. 2019 Sep 9;12:1756286419873518. doi: 10.1177/1756286419873518. eCollection 2019.
PubMed 31523280Spencer DD, Jacobi J, Juenke JM, Fleck JD, Kays MB. Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients. Pharmacotherapy. 2011 Oct;31(10):934-41. doi: 10.1592/phco.31.10.934.
PubMed 21950640Cotta MO, Abdul-Aziz MH, Frey OR, Sime FB, Roberts JA, Roehr AC. What Are the Predictors for Achieving Therapeutic Levetiracetam Serum Concentrations in Adult Neurological Patients? Ther Drug Monit. 2020 Aug;42(4):626-630. doi: 10.1097/FTD.0000000000000731.
PubMed 31977751Klein P, Herr D, Pearl PL, Natale J, Levine Z, Nogay C, Sandoval F, Trzcinsky S, Atabaki SM, Tsuchida T, van den Anker J, Soldin SJ, He J, McCarter R. Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy. Epilepsy Behav. 2012 Aug;24(4):457-61. doi: 10.1016/j.yebeh.2012.05.011. Epub 2012 Jul 7.
PubMed 22771222Uges JW, van Huizen MD, Engelsman J, Wilms EB, Touw DJ, Peeters E, Vecht CJ. Safety and pharmacokinetics of intravenous levetiracetam infusion as add-on in status epilepticus. Epilepsia. 2009 Mar;50(3):415-21. doi: 10.1111/j.1528-1167.2008.01889.x. Epub 2008 Nov 17.
PubMed 19054418Udy A, Boots R, Senthuran S, Stuart J, Deans R, Lassig-Smith M, Lipman J. Augmented creatinine clearance in traumatic brain injury. Anesth Analg. 2010 Dec;111(6):1505-10. doi: 10.1213/ANE.0b013e3181f7107d. Epub 2010 Nov 3.
PubMed 21048095
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Analysis of Levetiracetam Prophylaxis in Critically Ill Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04836481
- Acronym / sponsor ID
- 2020-0744
- Conditions
- Traumatic Brain Injury
- Keywords
- Levetiracetam, Seizure Prophylaxis, Pharmacokinetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims is to describe the pharmacokinetic properties of levetiracetam through measurement of serum concentrations in critically ill, severe traumatic brain injury patients.
Detailed description
Levetiracetam (LEV) is widely used for the prevention and treatment of seizures given its favorable pharmacokinetic profile. A strong correlation between serum concentrations and clinical efficacy has yet to be established; however, a target of 6-20 g/mL is recommended. Limited evidence exists supporting an optimal dosing strategy to achieve these target concentrations in neurocritically ill patients. Previous pharmacokinetic models suggest LEV 1000 mg every 8 hours achieves the highest proportion of therapeutic serum concentrations, but this dosing strategy has not been clinically studied in neurocritically ill patients. Additionally, only one phase two study has evaluated LEV pharmacokinetics in severe traumatic brain injury (TBI).
The aim of this study is to describe the pharmacokinetic properties of LEV through measurement of serum concentrations in critically ill, severe TBI patients. Secondarily, this study aims to develop a population pharmacokinetic model aimed at characterizing LEV dose optimization in severe TBI. An exploratory aim is to evaluate LEV pharmacodynamics in severe TBI patients through evaluation of physiologic, electrophysiologic and biochemical changes using multimodal monitoring or surface electroencephalogram (EEG), as available. A subgroup analysis will evaluate LEV pharmacokinetics in severe TBI patients with augmented renal clearance (ARC).
This prospective, single-center pharmacokinetic and pharmacodynamic study will include critically ill patients receiving intravenous LEV for seizure prophylaxis following severe TBI. Patients with severe TBI qualifying for multimodal monitoring will receive LEV 1000 mg every 8 hours (LEV8) per institutional practice. All other severe TBI patients will receive LEV 1000 mg every 12 hours (LEV12) according to institution practice. Patients with renal dysfunction (creatinine clearance < 50 mL/min) will be excluded. All patients will have five serum samples collected following the sixth or greater consecutive dose. Patients receiving LEV8 will have samples collected at 0.5, 1, 4, 6, and 8 hours. Patients receiving LEV12 will have samples collected at 0.5, 1, 4, 8, and 12 hours. Serum concentrations will be analyzed with pharmacokinetic modeling and Monte Carlo simulations. LEV pharmacodynamics will be evaluated in patients receiving multimodal monitoring or surface EEG, as available. Analysis of ARC will include patients with Augmented Renal Clearance in Trauma Intensive Care (ARTIC) score >6 during sampling.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEV8 | – | Other: Serum Sample CollectionLevetiracetam 1000 mg every 8 hours |
| LEV12 | – | Other: Serum Sample CollectionLevetiracetam 1000 mg every 12 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study will be patients with severe traumatic brain injury, defined as a post-resuscitation GCS 3-8 with or without CT abnormalities who are receiving intravenous levetiracetam 1000 mg every 8 or every 12 hours for seizure prophylaxis.
Key inclusion criteria (2 listed)
- Admitted to the neurosurgical intensive care unit or surgical intensive care unit following severe traumatic brain injury (post-resuscitation GCS 3-8 with or without CT abnormalities)
- Receiving intravenous levetiracetam for seizure prophylaxis at a dose of 1000 mg every 12 hours or 1000 mg every 8 hours at time of enrollment
Key exclusion criteria (8 listed)
- Known history of epilepsy or seizure disorder
- Taking antiseizure medication prior to admission
- Taking medication with known effect on levetiracetam pharmacokinetics including carbamazepine, phenytoin, oxcarbazepine, mefloquine, methotrexate, mianserin, or orlistat
- Weight < 50 kg
- Anticipated survival <72 hours from injury, as deemed by the primary neurosurgical provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Sample CollectionEach patient will have 5 serum samples collected for analysis after a minimum six consecutive doses. Patients receiving LEV8 will have sampled collected at hours 0.5, 1, 4, 6, and 8. Patients receiving LEV12 will have sampled collected at hours 0.5, 1, 4, 8, and 12. | Other | LEV12, LEV8 |
Primary outcome
Serum Levetiracetam Concentration 1
Time frame: Hour 0.5
Serum levetiracetam concentration collected at 0.5 hours after target dose for sampling
Serum Levetiracetam Concentration 2
Time frame: Hour 1
Serum levetiracetam concentration collected at hour 1 after target dose for sampling
Serum Levetiracetam Concentration 3
Time frame: Hour 4
Serum levetiracetam concentration collected at hour 4 after target dose for sampling
Serum Levetiracetam Concentration 4
Time frame: Hour 6-8
Serum levetiracetam concentration collected at hour 6 (patients receiving every 8 hour levetiracetam) or hour 8 (patients receiving every 12 hour levetiracetam)
Serum Levetiracetam Concentration 5
Time frame: Hour 8-12
Serum levetiracetam concentration collected at hour 8 (patients receiving every 8 hour levetiracetam) or hour 12 (patients receiving every 12 hour levetiracetam)
10 secondary outcomes
Intracranial Pressure
Time frame: Baseline to Day 7
Cerebral Perfusion Pressure
Time frame: Baseline to Day 7
Pressure Reactivity Index
Time frame: Baseline to Day 7
Cerebral Blood Flow
Time frame: Baseline to Day 7
Cerebral Microdialysis Glucose Concentration
Time frame: Baseline to Day 7
Cerebral Microdialysis Pyruvate Concentration
Time frame: Baseline to Day 7
Cerebral Microdialysis Lactate Concentration
Time frame: Baseline to Day 7
Cerebral Microdialysis Glutamate Concentration
Time frame: Baseline to Day 7
Cerebral Microdialysis Glycerol Concentration
Time frame: Baseline to Day 7
ARTIC Score
Time frame: Hour 0.5 (Collected at time of first serum sample collection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 30723936Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.
- Background: PubMed 24277723Rowe AS, Goodwin H, Brophy GM, Bushwitz J, Castle A, Deen D, Johnson D, Lesch C, Liang N, Potter E, Roels C, Samaan K, Rhoney DH; Neurocritical Care Society Pharmacy Section. Seizure prophylaxis in neurocritical care: a review of evidence-based support. Pharmacotherapy. 2014;34(4):396-409. doi: 10.1002/phar.1374. Epub 2013 Nov 26.
- Background: PubMed 28129261Barletta JF, Mangram AJ, Byrne M, Sucher JF, Hollingworth AK, Ali-Osman FR, Shirah GR, Haley M, Dzandu JK. Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system. J Trauma Acute Care Surg. 2017 Apr;82(4):665-671. doi: 10.1097/TA.0000000000001387.
- Results publication: PubMed 27307089Zangbar B, Khalil M, Gruessner A, Joseph B, Friese R, Kulvatunyou N, Wynne J, Latifi R, Rhee P, O'Keeffe T. Levetiracetam Prophylaxis for Post-traumatic Brain Injury Seizures is Ineffective: A Propensity Score Analysis. World J Surg. 2016 Nov;40(11):2667-2672. doi: 10.1007/s00268-016-3606-y.
- Results publication: PubMed 25169249Gabriel WM, Rowe AS. Long-term comparison of GOS-E scores in patients treated with phenytoin or levetiracetam for posttraumatic seizure prophylaxis after traumatic brain injury. Ann Pharmacother. 2014 Nov;48(11):1440-4. doi: 10.1177/1060028014549013. Epub 2014 Aug 28.
- Results publication: PubMed 23425733Inaba K, Menaker J, Branco BC, Gooch J, Okoye OT, Herrold J, Scalea TM, Dubose J, Demetriades D. A prospective multicenter comparison of levetiracetam versus phenytoin for early posttraumatic seizure prophylaxis. J Trauma Acute Care Surg. 2013 Mar;74(3):766-71; discussion 771-3. doi: 10.1097/TA.0b013e3182826e84.
- Results publication: PubMed 18828701Jones KE, Puccio AM, Harshman KJ, Falcione B, Benedict N, Jankowitz BT, Stippler M, Fischer M, Sauber-Schatz EK, Fabio A, Darby JM, Okonkwo DO. Levetiracetam versus phenytoin for seizure prophylaxis in severe traumatic brain injury. Neurosurg Focus. 2008 Oct;25(4):E3. doi: 10.3171/FOC.2008.25.10.E3.
- Results publication: PubMed 19898966Szaflarski JP, Sangha KS, Lindsell CJ, Shutter LA. Prospective, randomized, single-blinded comparative trial of intravenous levetiracetam versus phenytoin for seizure prophylaxis. Neurocrit Care. 2010 Apr;12(2):165-72. doi: 10.1007/s12028-009-9304-y.
- Results publication: PubMed 16886975Ramael S, Daoust A, Otoul C, Toublanc N, Troenaru M, Lu ZS, Stockis A. Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study. Epilepsia. 2006 Jul;47(7):1128-35. doi: 10.1111/j.1528-1167.2006.00586.x.
- Results publication: PubMed 31523280Steinhoff BJ, Staack AM. Levetiracetam and brivaracetam: a review of evidence from clinical trials and clinical experience. Ther Adv Neurol Disord. 2019 Sep 9;12:1756286419873518. doi: 10.1177/1756286419873518. eCollection 2019.
- Results publication: PubMed 21950640Spencer DD, Jacobi J, Juenke JM, Fleck JD, Kays MB. Steady-state pharmacokinetics of intravenous levetiracetam in neurocritical care patients. Pharmacotherapy. 2011 Oct;31(10):934-41. doi: 10.1592/phco.31.10.934.
- Results publication: PubMed 31977751Cotta MO, Abdul-Aziz MH, Frey OR, Sime FB, Roberts JA, Roehr AC. What Are the Predictors for Achieving Therapeutic Levetiracetam Serum Concentrations in Adult Neurological Patients? Ther Drug Monit. 2020 Aug;42(4):626-630. doi: 10.1097/FTD.0000000000000731.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Schuman Harlan, PharmD principal investigator
University of Cincinnati
Shaun Keegan, PharmD principal investigator
University of Cincinnati
Carolyn Philpott, PharmD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Levetiracetam Concentration 1 (time frame: Hour 0.5). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836481, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.