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Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Subarachnoid Hemorrhage; Seizures

Intervention: levetiracetam (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
J D Mocco, MS, MD, Principal Investigator, Affiliation: Vanderbilt University
Michael C Dewan, MD, Study Director, Affiliation: Vanderbilt University

Overall contact:
J D Mocco, MD, MS, Phone: 615-343-6485, Email: jmocco@vanderbilt.ed

Summary

The purpose of this study is to determine the feasibility of prospectively enrolling and randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam or not to receive levetiracetam, and documenting in-hospital and follow-up clinical variables.

Clinical Details

Official title: Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Randomization Yield

Secondary outcome: Protocol Adherence Yield

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ≥ 18 years of age

- ≤ 75 years of age

- Newly diagnosed aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

- One or more antiepileptic medication is taken as a pre-admission medication

- Seizure occurrence in the field or in the emergency department, or anytime before

consent could be obtained

- Inability to obtain informed consent from the patient, or from the patient's

appropriate surrogate

Locations and Contacts

J D Mocco, MD, MS, Phone: 615-343-6485, Email: jmocco@vanderbilt.ed

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Not yet recruiting
Chesney S Oravec, BA, Phone: 615-343-6485, Email: chesney.s.oravec@vanderbilt.edu
Bree Burks, RN, BSN, Phone: 615-875-7606, Email: bree.burks@vanderbilt.edu
Michael C Dewan, MD, Sub-Investigator
J D Mocco, MD, MS, Principal Investigator
Additional Information

Related publications:

Butzkueven H, Evans AH, Pitman A, Leopold C, Jolley DJ, Kaye AH, Kilpatrick CJ, Davis SM. Onset seizures independently predict poor outcome after subarachnoid hemorrhage. Neurology. 2000 Nov 14;55(9):1315-20.

Choi KS, Chun HJ, Yi HJ, Ko Y, Kim YS, Kim JM. Seizures and Epilepsy following Aneurysmal Subarachnoid Hemorrhage : Incidence and Risk Factors. J Korean Neurosurg Soc. 2009 Aug;46(2):93-8. doi: 10.3340/jkns.2009.46.2.93. Epub 2009 Aug 31.

Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.

Hart RG, Byer JA, Slaughter JR, Hewett JE, Easton JD. Occurrence and implications of seizures in subarachnoid hemorrhage due to ruptured intracranial aneurysms. Neurosurgery. 1981 Apr;8(4):417-21.

Hovinga CA. Levetiracetam: a novel antiepileptic drug. Pharmacotherapy. 2001 Nov;21(11):1375-88. Review.

Kvam DA, Loftus CM, Copeland B, Quest DO. Seizures during the immediate postoperative period. Neurosurgery. 1983 Jan;12(1):14-7.

Lin CL, Dumont AS, Lieu AS, Yen CP, Hwang SL, Kwan AL, Kassell NF, Howng SL. Characterization of perioperative seizures and epilepsy following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2003 Dec;99(6):978-85.

Little AS, Kerrigan JF, McDougall CG, Zabramski JM, Albuquerque FC, Nakaji P, Spetzler RF. Nonconvulsive status epilepticus in patients suffering spontaneous subarachnoid hemorrhage. J Neurosurg. 2007 May;106(5):805-11.

Mink S, Muroi C, Seule M, Bjeljac M, Keller E. Levetiracetam compared to valproic acid: plasma concentration levels, adverse effects and interactions in aneurysmal subarachnoid hemorrhage. Clin Neurol Neurosurg. 2011 Oct;113(8):644-8. doi: 10.1016/j.clineuro.2011.05.007. Epub 2011 Jun 23.

Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17.

Murphy-Human T, Welch E, Zipfel G, Diringer MN, Dhar R. Comparison of short-duration levetiracetam with extended-course phenytoin for seizure prophylaxis after subarachnoid hemorrhage. World Neurosurg. 2011 Feb;75(2):269-74. doi: 10.1016/j.wneu.2010.09.002.

Beeton AG, Upton PM, Shipton EA. The case for patient-controlled analgesia. Inter-patient variation in postoperative analgesic requirements. S Afr J Surg. 1992 Mar;30(1):5-6.

Rhoney DH, Tipps LB, Murry KR, Basham MC, Michael DB, Coplin WM. Anticonvulsant prophylaxis and timing of seizures after aneurysmal subarachnoid hemorrhage. Neurology. 2000 Jul 25;55(2):258-65.

Rosengart AJ, Huo JD, Tolentino J, Novakovic RL, Frank JI, Goldenberg FD, Macdonald RL. Outcome in patients with subarachnoid hemorrhage treated with antiepileptic drugs. J Neurosurg. 2007 Aug;107(2):253-60.

Shah D, Husain AM. Utility of levetiracetam in patients with subarachnoid hemorrhage. Seizure. 2009 Dec;18(10):676-9. doi: 10.1016/j.seizure.2009.09.003. Epub 2009 Oct 27.

Sundaram MB, Chow F. Seizures associated with spontaneous subarachnoid hemorrhage. Can J Neurol Sci. 1986 Aug;13(3):229-31.

Szaflarski 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.

Usami K, Saito N. Prophylactic anticonvulsants after subarachnoid hemorrhage. World Neurosurg. 2011 Feb;75(2):214. doi: 10.1016/j.wneu.2010.09.035.

Starting date: January 2014
Last updated: September 1, 2013

Page last updated: August 23, 2015

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