Cordonnier C, Demchuk A, Ziai W, Anderson CS Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6. Erratum In: Lancet. 2019 Feb 2;393(10170):406.
Gradisek P, Osredkar J, Korsic M, Kremzar B Multiple indicators model of long-term mortality in traumatic brain injury. Brain Inj. 2012;26(12):1472-81. doi: 10.3109/02699052.2012.694567. Epub 2012 Jun 21.
Gruenbaum SE, Bilotta F Postoperative ICU management of patients after subarachnoid hemorrhage. Curr Opin Anaesthesiol. 2014 Oct;27(5):489-93. doi: 10.1097/ACO.0000000000000111.
Gruenbaum SE, Zlotnik A, Gruenbaum BF, Hersey D, Bilotta F Pharmacologic Neuroprotection for Functional Outcomes After Traumatic Brain Injury: A Systematic Review of the Clinical Literature. CNS Drugs. 2016 Sep;30(9):791-806. doi: 10.1007/s40263-016-0355-2.
Lauritzen M, Dreier JP, Fabricius M, Hartings JA, Graf R, Strong AJ Clinical relevance of cortical spreading depression in neurological disorders: migraine, malignant stroke, subarachnoid and intracranial hemorrhage, and traumatic brain injury. J Cereb Blood Flow Metab. 2011 Jan;31(1):17-35. doi: 10.1038/jcbfm.2010.191. Epub 2010 Nov 3.
Macdonald RL, Schweizer TA Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.
Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009 Jul;8(7):635-42. doi: 10.1016/S1474-4422(09)70126-7. Epub 2009 Jun 6.
Seder DB, Mayer SA Critical care management of subarachnoid hemorrhage and ischemic stroke. Clin Chest Med. 2009 Mar;30(1):103-22, viii-ix. doi: 10.1016/j.ccm.2008.11.004.
Shah S, Kimberly WT Today's Approach to Treating Brain Swelling in the Neuro Intensive Care Unit. Semin Neurol. 2016 Dec;36(6):502-507. doi: 10.1055/s-0036-1592109. Epub 2016 Dec 1.
Sheriff FG, Hinson HE Pathophysiology and clinical management of moderate and severe traumatic brain injury in the ICU. Semin Neurol. 2015 Feb;35(1):42-9. doi: 10.1055/s-0035-1544238. Epub 2015 Feb 25.
Welling L, Welling MS, Teixeira MJ, Figueiredo EG Cortical spread depolarization and ketamine: a revival of an old drug or a new era of neuroprotective drugs? World Neurosurg. 2015 Apr;83(4):396-7. doi: 10.1016/j.wneu.2015.01.006. Epub 2015 Jan 31. No abstract available.
Zhou YT, Tong DM, Wang SD, Ye S, Xu BW, Yang CX Acute spontaneous intracerebral hemorrhage and traumatic brain injury are the most common causes of critical illness in the ICU and have high early mortality. BMC Neurol. 2018 Aug 27;18(1):127. doi: 10.1186/s12883-018-1127-z.
S-ketamine for Cortical Spreading Depolarisation in Patients With Severe Acute Brain Injury
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.