Subarachnoid Hemorrhage — Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Citation(s)
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.
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.
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.
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.
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.
Pilot Study of Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.