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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group will not receive levetiracetam as seizure prophylaxis. | |
| Treatment Group | Active Comparator | levetiracetam 500mg in adults, twice daily, administered by mouth, per tube, or IV. The route of administration will be dependent upon the patient's clinical status and ability to tolerate each form. In descending order of preference, route of administration will be: oral, per tube, IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Randomization Yield | The primary outcome will be the number of patients randomized to either levetiracetam administration or no administration of levetiracetam divided by the total number of aneurysmal subarachnoid hemorrhage patients who present to the Vanderbilt University Emergency Department or are directly admitted to the Neuro Intensive Care Unit. (Unit of Measure: numeric fraction) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol Adherence Yield | The Protocol Adherence Yield is calculated by dividing the number of patients completing the study without incurring a protocol deviation by the total number of patients randomized. (Unit of Measure: numeric fraction) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) | mRS - modified Rankin Scale (0-6): 0 - no symptoms
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J D Mocco, MS, MD | Vanderbilt University | Principal Investigator |
| Michael C Dewan, MD | Vanderbilt University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11087774 | Background | 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. doi: 10.1212/wnl.55.9.1315. | |
| 19763209 | Background | 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. |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| hospital discharge, 1-month, 3-months |
| Glasgow Outcomes Scale-Extended (GOSE) | GOSE - Glasgow Outcomes Scale - Extended (1-8):
| hospital discharge, 1-month, 3-month |
| 22556195 | Background | 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. |
| 7242892 | Background | 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. doi: 10.1227/00006123-198104000-00002. |
| 11714211 | Background | Hovinga CA. Levetiracetam: a novel antiepileptic drug. Pharmacotherapy. 2001 Nov;21(11):1375-88. doi: 10.1592/phco.21.17.1375.34432. |
| 6828220 | Background | Kvam DA, Loftus CM, Copeland B, Quest DO. Seizures during the immediate postoperative period. Neurosurgery. 1983 Jan;12(1):14-7. doi: 10.1227/00006123-198301000-00003. |
| 14705724 | Background | 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. doi: 10.3171/jns.2003.99.6.0978. |
| 17542523 | Background | 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. doi: 10.3171/jns.2007.106.5.805. |
| 21703756 | Background | 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. |
| 16139655 | Background | 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. doi: 10.1016/S0140-6736(05)67214-5. |
| 21492729 | Background | 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. |
| 1566203 | Background | 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. |
| 10908901 | Background | 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. doi: 10.1212/wnl.55.2.258. |
| 17695377 | Background | 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. doi: 10.3171/JNS-07/08/0253. |
| 19864168 | Background | 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. |
| 3742338 | Background | Sundaram MB, Chow F. Seizures associated with spontaneous subarachnoid hemorrhage. Can J Neurol Sci. 1986 Aug;13(3):229-31. doi: 10.1017/s0317167100036325. |
| 19898966 | Background | 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. |
| 21492717 | Background | Usami K, Saito N. Prophylactic anticonvulsants after subarachnoid hemorrhage. World Neurosurg. 2011 Feb;75(2):214. doi: 10.1016/j.wneu.2010.09.035. No abstract available. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |