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First Clinical Studies and Trials

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Abstract

This chapter introduces 12 landmark trials that define the field. These clinical trials involve the first testing of drugs in large groups of patients and modified or altered practice.

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References

  1. Adams Jr HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke. A guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology, and Intervention Council and the Atherosclerotic peripheral vascular disease and quality of care outcomes in research interdisciplinary working groups. Circulation. 2007;115:e478–534.

    Article  PubMed  Google Scholar 

  2. Al-Khotani A, Parrent A, Jenkins ME, et al. Decompressive craniectomy in stroke. Can J Neurol Sci. 2010;37:868–9.

    PubMed  CAS  Google Scholar 

  3. Allen GS, Ahn HS, Preziosi TJ, et al. Cerebral arterial spasm – a controlled trial of nimodipine in patients with subarachnoid hemorrhage. N Engl J Med. 1983;308:619–24.

    Article  PubMed  CAS  Google Scholar 

  4. Allen GS, Ahn HS, Preziosi TJ, et al. Cerebral arterial spasm – a controlled trial of nimodipine in patients with subarachnoid hemorrhage. N Engl J Med. 1983;308:619–24.

    Article  PubMed  CAS  Google Scholar 

  5. Allen GS, Bahr AL. Cerebral arterial spasm. 10. Reversal of acute and chronic spasm in dogs with orally administered nifedipine. Neurosurgery. 1979;4:43–7.

    Article  PubMed  CAS  Google Scholar 

  6. Allen GS, Banghart SB. Cerebral arterial spasm. 9. In vitro effects of nifedipine on serotonin-, phenylephrine-, and potassium-induced contractions of canine basilar and femoral arteries. Neurosurgery. 1979;4:37–42.

    Article  PubMed  CAS  Google Scholar 

  7. American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2005;112:IV1–211.

    Google Scholar 

  8. Anderson DK, Saunders RD, Demediuk P, et al. Lipid hydrolysis and peroxidation in injured spinal cord: partial protection with methylprednisolone or vitamin E and selenium. Cent Nerv Syst Trauma. 1985;2:257–67.

    PubMed  CAS  Google Scholar 

  9. Arrich J, Holzer M, Herkner H, et al. Cochrane corner: hypothermia for neuroprotection in adults after cardiopulmonary resuscitation. Anesth Analg. 2010;110:1239.

    PubMed  Google Scholar 

  10. Auer LM. Pial arterial and venous reaction to intravenous infusion of nimodipine in cats. J Neurosurg Sci. 1982;26:213–8.

    PubMed  CAS  Google Scholar 

  11. Auer LM, Ito Z, Suzuki A, et al. Prevention of symptomatic vasospasm by topically applied nimodipine. Acta Neurochir (Wien). 1982;63:297–302.

    Article  CAS  Google Scholar 

  12. Batjer HH, Reisch JS, Allen BC, et al. Failure of surgery to improve outcome in hypertensive putaminal hemorrhage. A prospective randomized trial. Arch Neurol. 1990;47:1103–6.

    Article  PubMed  CAS  Google Scholar 

  13. Bauer RB, Tellez H. Dexamethasone as treatment in cerebrovascular disease. 2. A controlled study in acute cerebral infarction. Stroke. 1973;4:547–55.

    Article  PubMed  CAS  Google Scholar 

  14. Bernard S. Hypothermia after cardiac arrest: expanding the therapeutic scope. Crit Care Med. 2009;37:S227–33.

    Article  PubMed  Google Scholar 

  15. Black P, Markowitz RS. Experimental spinal cord injury in monkeys: comparison of steroids and local hypothermia. Surg Forum. 1971;22:409–11.

    PubMed  CAS  Google Scholar 

  16. Bladin PF. Status epilepticus, the grim reaper of the mental health system in early Victoria. J Clin Neurosci. 2003;10:655–60.

    Article  PubMed  Google Scholar 

  17. Braughler JM, Hall ED. Correlation of methylprednisolone levels in eat spinal cord with its effects on (Na+ + K+)-ATPase, lipid peroxidation, and alpha motor neuron function. J Neurosurg. 1983;56:838–44.

    Google Scholar 

  18. Brettle RP, Gross M, Legg NJ, et al. Treatment of acute polyneuropathy by plasma exchange. Lancet. 1978;18:1100.

    Article  Google Scholar 

  19. Bril V, Ilse WK, Pearce R, et al. Pilot trial of immunoglobulin versus plasma exchange in patients with Guillain-Barré syndrome. Neurology. 1996;46:100–3.

    Article  PubMed  CAS  Google Scholar 

  20. Broderick J, Brott T, Duldner JE, et al. Volume of intracerebral hemorrhage: a powerful and easy way to use prediction of 30 year mortality. Stroke. 1993;24:987–93.

    Article  PubMed  CAS  Google Scholar 

  21. Brott T, Broderick J, Kothari R, et al. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke. 1990;28:1–5.

    Article  Google Scholar 

  22. Bruckmann H, Ferbert A, del Zoppo GJ, et al. Acute vertebral basilar thrombosis: angiologic-clinical comparison and therapeutic implications. Acta Radiol. 1987;369:38–42.

    Google Scholar 

  23. Buchwald B, Ahangari R, Weishaupt A, et al. Intravenous immunoglobulins neutralize blocking antibodies in Guillain-Barré syndrome. Ann Neurol. 2002;51:673–80.

    Article  PubMed  CAS  Google Scholar 

  24. Campbell JB, DeCrescito V, Tomasula JJ, et al. Experimental treatment of spinal cord contusions in the cat. Surg Neurol. 1973;1:102–6.

    PubMed  CAS  Google Scholar 

  25. Campbell JB, DeCrescito V, Tomasula JJ, et al. Effects of antifibrinolytic and steroid therapy on the contused spinal cord cats. J Neurosurg. 1974;40:726–33.

    Article  PubMed  CAS  Google Scholar 

  26. Carter CH. Use of parenteral diphenylhydantoin (Dilantin) sodium in control of status epilepticus. AMA Arch Neurol Psychiatry. 1958;79:136–7.

    Article  PubMed  CAS  Google Scholar 

  27. Castro LH, Ropper AH. Human immune globulin infusion in Guillain-Barré syndrome: worsening during and after treatment. Neurology. 1993;43:1034–6.

    Article  PubMed  CAS  Google Scholar 

  28. Chen JW, Waterlain CG. Status epilepticus: pathophysiology and management in adults. Lancet Neurol. 2006;5:246–56.

    Article  PubMed  Google Scholar 

  29. Claassen J, Hirsch LJ, Emerson RG, et al. Treatment of refractory status epilepticus with pentobarbital, propofol, or midazolam: a systematic review. Epilepsia. 2002;43:146–53.

    Article  PubMed  CAS  Google Scholar 

  30. Clark K, Nash TM, Hutchison GC. The failure of circumferential craniotomy in acute traumatic cerebral swelling. J Neurosurg. 1968;29:367–71.

    Article  PubMed  CAS  Google Scholar 

  31. Clark LP, Prout TP. Status epilepticus: a clinical and pathological study in epilepsy. Am J Insanity. 1904;61:1081–3.

    Google Scholar 

  32. Cohen RJ, Allen GS. Cerebral arterial spasm: the role of calcium in in vitro and in vivo analysis of treatment with nifedipine and nimodipine. In: Wilkins RH, editor. Cerebral arterial spasm. Baltimore: Williams & Wilkins; 1980. p. 527–32.

    Google Scholar 

  33. Coleman WP, Benzel D, Cahill DW, et al. A critical appraisal of the reporting of the national acute spinal cord injury studies (II and III) of methylprednisolone in acute spinal cord injury. J Spinal Disord. 2000;13:185–99.

    Article  PubMed  CAS  Google Scholar 

  34. Collier GK. The intravenous use of paraldehyde. NY State J Med. 1914;14

    Google Scholar 

  35. Cooper DJ, Rosenfeld JV, Murray L, et al. Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med. 2011;364:1493–502.

    Article  PubMed  CAS  Google Scholar 

  36. Cushing H. The establishment of cerebral hernia as a decompressive measure for inaccessible brain tumors; with the description of intermuscular methods of making the bone defect in temporal and occipital regions. Surg Gynecol Obstet. 1905;1: 297–314.

    Google Scholar 

  37. De la Torre JC, Johnson CM, Goode DJ, et al. Pharmacologic treatment and evaluation of permanent experimental spinal cord trauma. Neurology. 1975;25:508–14.

    Article  Google Scholar 

  38. Del Zoppo GJ. tPA and scuPA: new concepts in the treatment of acute ischemic stroke. In: Poeck K, Ringelstein EB, Hacke W, editors. New trends in diagnosis and management of stroke. Berlin: Springer; 1987. p. 115–27.

    Chapter  Google Scholar 

  39. del Zoppo GJ, Zeumer H, Harker LA. Thrombolytic therapy in acute stroke: possibilities and hazards. Stroke. 1986;17:595–607.

    Article  PubMed  Google Scholar 

  40. Demchuk AM, Dowlatshahi D, Rodriguez-Luna D et al. Prediction of hematoma growth and outcome in patients with intracerebral hemorrhage using the CT-angiography spot sign (PREDICT): A prospective observational study. Lancet Neurol. 2012;11:307–14.

    PubMed  CAS  Google Scholar 

  41. Desai P, Prasad K. Dexamethasone is not necessarily unsafe in primary supratentorial intracerebral hemorrhage. J Neurol Neurosurg Psychiatry. 1998;65:799–800.

    Article  PubMed  CAS  Google Scholar 

  42. Diringer MN, Skolnick BE, Mayer SA, et al. Thromboembolic events with recombinant activated factor VII in spontaneous intracerebral hemorrhage: results from the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial. Stroke. 2010;41:48–53.

    Article  PubMed  CAS  Google Scholar 

  43. Dreler JP, Windmuller O, Petzold G, et al. Ischemia triggered by red blood cell products in the subarachnoid space is inhibited by nimodipine administration or moderate volume expansion/hemodilution in rats. Neurosurgery. 2002;51:1457–65.

    Google Scholar 

  44. Ducker TB, Hamit HF. Experimental treatments of acute spinal cord injury. J Neurosurg. 1969;30:693–7.

    Article  PubMed  CAS  Google Scholar 

  45. Dumas F, Grimaldi D, Zuber B, et al. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients? Insights from a large registry. Circulation. 2011;123:877–86.

    Article  PubMed  Google Scholar 

  46. Feasby T, Banwell B, Benstead T, et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev. 2007;21:S57–107.

    Article  PubMed  Google Scholar 

  47. Feigin VL, Anderson N, Rinkel GJ, et al. Corticos­teroids for aneurysmal subarachnoid hemorrhage and primary intracerebral hemorrhage. Cochrane Database Syst Rev. 2005;(3):CD004583.

    Google Scholar 

  48. Flamm ES, Adams Jr HP, Beck DW, et al. Dose-escalation study of intravenous nicardipine in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 1988;68:393–400.

    Article  PubMed  CAS  Google Scholar 

  49. Freeman WD, Brott TG, Barrett KM, et al. Recombinant factor VIIa for rapid reversal of warfarin anticoagulation in acute intracranial hemorrhage. Mayo Clin Proc. 2004;79:1495–500.

    Article  PubMed  CAS  Google Scholar 

  50. French Cooperative Group on plasma exchange in Guillain-Barré syndrome. Appropriate number of plasma exchanges in Guillain-Barré syndrome. Ann Neurol. 1997;41:298–306.

    Google Scholar 

  51. Furlan AJ. Acute stroke therapy: Beyond IV tPA. Cleve Clin J Med. 2002;69:730–34.

    Google Scholar 

  52. French Cooperative Group on plasma exchange in Guillain-Barré syndrome: efficiency of plasma exchange in Guillain-Barré syndrome: role of replacement fluids. Ann Neurol. 1987;22:753–61.

    Google Scholar 

  53. Furlan A, Higashida R, Wechsler L, et al. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in acute cerebral thromboembolism. JAMA. 1999;282:2003–11.

    Article  PubMed  CAS  Google Scholar 

  54. Galandiuk S, Raque G, Appel S, et al. The two-edged sword of large-dose steroids for spinal cord trauma. Ann Surg. 1993;218:419–25.

    Article  PubMed  CAS  Google Scholar 

  55. Gibbs JR, O’Gorman P. Fibrinolysis in subarachnoid hemorrhage. Postgrad Med J. 1967;43:779–84.

    Article  PubMed  CAS  Google Scholar 

  56. Gonner F, Remonda L, Mattle H, et al. Local intra-arterial thrombolysis in acute ischemic stroke. Stroke. 1998;29:1894–900.

    Article  PubMed  CAS  Google Scholar 

  57. Gowers WRG. Epilepsy and other chronic convulsive diseases. 2nd ed. London: JA Churchill; 1901.

    Google Scholar 

  58. Guillain-Barré Syndrome Steroid Trial Group. Double-blind trial of intravenous methylprednisolone in Guillain-Barré syndrome. Lancet 1993;341:586–90.

    Google Scholar 

  59. Hacke W, del Zoppo GJ, Harker LA. Thrombosis and cerebrovascular disease. In: Poeck K, Ringelstein EB, Hacke W, editors. New trends in diagnosis and management of stroke. Berlin: Springer; 1987. p. 59–74.

    Chapter  Google Scholar 

  60. Hacke W, Schwab S, Horn M, et al. “Malignant” middle cerebral artery territory infarction: clinical course and prognostic signs. Arch Neurol. 1996;53:309–15.

    Article  PubMed  CAS  Google Scholar 

  61. Haley Jr EC, Kassell NF, Torner J. A randomized controlled trial of high-dose intravenous nicardipine in aneurysmal subarachnoid hemorrhage. A report of the Cooperative Aneurysm Study. J Neurosurg. 1993;78:537–47.

    Article  PubMed  Google Scholar 

  62. Haley Jr EC, Kassell NF, Torner JC. A randomized trial of nicardipine in subarachnoid hemorrhage: angiographic and transcranial Doppler ultrasound results. A report of the Cooperative Aneurysm Study. J Neurosurg. 1993;78:548–53.

    Article  PubMed  Google Scholar 

  63. Haley Jr EC, Kassell NF, Torner JC, et al. A randomized trial of two doses of nicardipine in aneurysmal subarachnoid hemorrhage. A report of the Cooperative Aneurysm Study. J Neurosurg. 1994;80:788–96.

    Article  PubMed  Google Scholar 

  64. Han DH, Lee S. Effect of nimodipine treatment on outcome in surgical cases of aneurysmal SAH. J Neurosurg. 1993;78:346A.

    Google Scholar 

  65. Hanggi D, Turowski B, Beseoglu K, et al. Steiger HJ. Intraarterial nimodipine for severe cerebral vasospasm after aneurysmal subarachnoid hemorrhage: influence on clinical course and cerebral perfusion. AJNR Am J Neuroradiol. 2008;29:1053–60.

    Article  PubMed  CAS  Google Scholar 

  66. Harrigan MR, Rajneesh KF, Ardelt AA, Fisher 3rd WS. Short-term antifibrinolytic therapy before early aneurysm treatment in subarachnoid hemorrhage: effects on rehemorrhage, cerebral ischemia, and hydrocephalus. Neurosurgery. 2010;67:935–9.

    Article  PubMed  Google Scholar 

  67. Heros RC, Zervas NT, Varsos V. Cerebral vasospasm after subarachnoid hemorrhage: an update. Ann Neurol. 1983;14:599–608.

    Article  PubMed  CAS  Google Scholar 

  68. Hillman J, Fridriksson S, Nilsson O, et al. Saveland H, Jakobsson KE. Immediate administration of tranexamic acid and reduced incidence of early rebleeding after aneurysmal subarachnoid hemorrhage: a prospective randomized study. J Neurosurg. 2002;97:771–8.

    Article  PubMed  CAS  Google Scholar 

  69. Hughes RA, Donofrio P, Bril V, et al. ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized placebo-controlled trial. Lancet Neurol. 2008;7:136–44.

    Article  PubMed  CAS  Google Scholar 

  70. Hughes RA, Raphael JC, Swan AV, et al. Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Database Syst Rev. 2006;(1):CD002063.

    Google Scholar 

  71. Hughes RA, Swan AV, Raphael JC, et al. Immunotherapy for Guillain-Barré syndrome; a systematic review. Brain. 2007;130:2245–57.

    Article  PubMed  Google Scholar 

  72. Hughes RA, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Data base Syst Rev. 2010;(6):CD002063.

    Google Scholar 

  73. Hughes RA, Wijdicks EFM, Barohn R, et al. Quality Standards Sub­committee of the American Academy of Neurology. Immunotherapy in Guillain-Barré syndrome. American Academy of Neurology practice parameter. Neurology. 2003;61:736–40.

    Article  PubMed  CAS  Google Scholar 

  74. Hughes RA, Wijdicks EFM, Benson E, et al. Supportive care for patients with Guillain-Barré syndrome. Arch Neurol. 2005;62:1194–8.

    Article  PubMed  Google Scholar 

  75. Hurlbert RJ, Hamilton MG. Methylprednisolone for acute spinal cord injury: 5-year practice reversal. Can J Neurol Sci. 2008;3:541–5.

    Google Scholar 

  76. Irani DN, Cornblath DR, Chaudhry V, et al. Relapse in Guillain-Barré syndrome after treatment with human immune globulin. Neurology. 1993;43:872–5.

    Article  PubMed  CAS  Google Scholar 

  77. Jahan R, Duckwiler GR, Kidwell CS, et al. Intraarterial thrombolysis for treatment of acute stroke: experience in 26 patients with long-term follow-up. AJNR Am J Neuroradiol. 1999;20:1291–9.

    PubMed  CAS  Google Scholar 

  78. Joseph M, Ziadi S, Nates J, et al. Increases in cardiac output can reverse flow deficits from vasospasm independent of blood pressure: a study using xenon computed tomographic measurement of cerebral blood flow. Neurosurgery. 2003;53:1044–51.

    Article  PubMed  Google Scholar 

  79. Juvela S, Heiskanen O, Poranen A, et al. The treatment of spontaneous intracerebral hemorrhage. A prospective randomized trial of surgical and conservative treatment. J Neurosurg. 1989;70:755–8.

    Article  PubMed  CAS  Google Scholar 

  80. Kassel NF, Peerless SJ, Durward QJ, et al. Treatment of ischemic deficits from vasospasm with intravascular volume expansion and induced arterial hypertension. Neurosurgery. 1982;11:337–43.

    Article  Google Scholar 

  81. Kastrau F, Wolter M, Huber W, et al. Recovery from aphasia after hemicraniectomy for infarction of the speech-dominant hemisphere. Stroke. 2005;36:825–9.

    Article  PubMed  Google Scholar 

  82. Kelley RE, Berger JR, Schienberg P, et al. Active bleeding in hypertensive intracerebral hemorrhage: computed tomography. Neurology. 1982;32:852–6.

    Article  PubMed  CAS  Google Scholar 

  83. Kendal BE, Lee BCB, Claveria E. Computed tomography and angiography in subarachnoid hemorrhage. Br J Radiol. 1976;49:483–501.

    Article  Google Scholar 

  84. Kleyweg RP, van der Meche FG, Meulstee J. Treatment of Guillain-Barré syndrome with high-dose gammaglobulin. Neurology. 1988;38:1639–41.

    Article  PubMed  CAS  Google Scholar 

  85. Kocher T. Die Therapie des Hirndruckes. In: Hölder A, editor. Hirnerschütterung, Hirndruck und chirurgische Eingriffe bei Hirnkrankheiten. Vienna: A Hölder; 1901. p. 262–6.

    Google Scholar 

  86. Korenkov AI, Pahnke J, Frei K, et al. Treatment with nimodipine or mannitol reduces programmed cell death and infarct size following focal cerebral ischemia. Neurosurg Rev. 2000;23:145–50.

    Article  PubMed  CAS  Google Scholar 

  87. Krieger DW, Demchuk AM, Kasner SE, et al. Early clinical and radiological predictors of fatal brain swelling in ischemic stroke. Stroke. 1999;30:287–92.

    Article  PubMed  CAS  Google Scholar 

  88. Kuboyama K, Safar P, Radovsky A, et al. Delay in cooling negates the beneficial effect of mild resuscitative cerebral hypothermia after cardiac arrest in dogs: a prospective, randomized study. Crit Care Med. 1993;21:1348–58.

    Article  PubMed  CAS  Google Scholar 

  89. Kuitwaard K, de Gelder J, Tio-Gillen AP, Hop WC, van Gelder T, van Toorenenbergen AW, et al. Pharmacokinetics of intravenous immunoglobulin and outcome in Guillain-Barré syndrome. Ann Neurol. 2009;66:597–603.

    Article  PubMed  CAS  Google Scholar 

  90. Lee KH, Lukovits T, Friedman JA. “Triple-H” therapy for cerebral vasospasm following subarachnoid hemorrhage. Neurocrit Care. 2006;4:68–76.

    Article  PubMed  Google Scholar 

  91. Leng LZ, Fink ME, Iadecola C. Spreading depolarization: a possible new culprit in the delayed cerebral ischemia of subarachnoid hemorrhage. Arch Neurol. 2011;68:31–6.

    Article  PubMed  Google Scholar 

  92. Lennihan L, Mayer SA, Fink ME, et al. Effect of hypervolemic therapy on cerebral blood flow after subarachnoid hemorrhage: a randomized controlled trial. Stroke. 2000;31:383–91.

    Article  PubMed  CAS  Google Scholar 

  93. Lin J, Hanigan WC, Tarantino M, et al. The use of recombinant activated factor VII to reverse warfarin-induced anticoagulation in patients with hemorrhages in the central nervous system: preliminary findings. J Neurosurg. 2003;98:737–40.

    Article  PubMed  CAS  Google Scholar 

  94. Maramattom BV, Bahn MM, Wijdicks EFM. Which patient fares worse after early deterioration due to swelling from hemispheric stroke? Neurology. 2004;63:2142–5.

    Article  PubMed  Google Scholar 

  95. Mayer SA, Solomon RA, Fink ME, et al. Effect of 5% albumin solution on sodium balance and blood volume after subarachnoid hemorrhage. Neuro­surgery. 1998;42:759–67.

    Article  PubMed  CAS  Google Scholar 

  96. McKissock W, Richardson A, Taylor J. Primary intracerebral hematoma: a controlled trial of surgical and conservative treatment in 180 unselected cases. Lancet. 1961;2:221–6.

    Article  Google Scholar 

  97. Meldrum B. Status epilepticus: the past and the future. Epilepsia. 2007;48:33–4.

    Article  PubMed  Google Scholar 

  98. Meyers PM, Schumacher HC, Connolly Jr ES, et al. Current status of endovascular stroke treatment. Circulation. 2011;123:2591–601.

    Article  PubMed  Google Scholar 

  99. Moody RA, Ruamsuke S, Mullan S. An evaluation of decompression in experimental head injury. J Neurosurg. 1968;29:586–90.

    Article  PubMed  CAS  Google Scholar 

  100. Morgenstern LB, Frankowski RF, Shedden P, Pasteur W, Grotta JC. Surgical treatment for intracerebral hemorrhage (STICH). A single-center, randomized clinical trial. Neurology. 1998;51:1359–63.

    Article  PubMed  CAS  Google Scholar 

  101. Neligan A, Shorvon SD. History of epilepsy 1909–2009: the ILAE Century. The history of status epilepticus and its treatment. Epilepsia. 2009;50:56–68.

    Article  PubMed  Google Scholar 

  102. Neligan A, Shorvon SD. The frequency and prognosis of convulsive status epilepticus of different causes: a systematic review. Arch Neurol. 2010;67:931–40.

    Article  PubMed  Google Scholar 

  103. Nielsen N, Friberg H, Gluud C, et al. Hypothermia after cardiac arrest should be further evaluated – a systematic review of randomised trials with meta-analysis and trial sequential analysis. Int J Cardiol. 2011;151:333–41.

    Article  PubMed  Google Scholar 

  104. Nielsen N, Hovdenes J, Nilsson S, et al. Outcome, timing and adverse events in therapeutic hypothermia after out-of-hospital cardiac arrest – a report from the Hypothermia Network Registry. Acta Anaesthesiol Scand. 2009;53:926–34.

    Article  PubMed  CAS  Google Scholar 

  105. Nolan JP, Morley PT, Hoek TL, Hickey RW, Advancement Life Support Task Force of the International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the Advancement Life Support Task Force of the International Liaison Committee on Resuscitation. Resuscitation. 2003;57:231–5.

    Article  PubMed  Google Scholar 

  106. Nolan JP, Neumar RW, Adrie C, et al. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication: a scientific statement from the International Liaison Committee on Resuscitation; the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; the Council on Stroke. Resuscitation. 2008;79:350–79.

    Article  PubMed  Google Scholar 

  107. Norris JW, Hachinski VC. High dose steroid treatment in cerebral infarction. BMJ. 1986;292:21–3.

    Article  PubMed  CAS  Google Scholar 

  108. Pandya KA, Weant KA, Cook AM. High-dose methylprednisolone in acute spinal cord injuries: proceed with caution. Orthopedics. 2010;33:327–31.

    Article  PubMed  Google Scholar 

  109. Patterson HA, Le Damon GA, Levi P. A comparative study of various methods of the administration of luminal in epilepsy. J Nerv Ment Dis. 1926;63:275.

    Article  Google Scholar 

  110. Peroutka SJ, Allen GS. Calcium channel antagonist binding sites labeled by 3H-nimodipine in human brain. J Neurosurg. 1983;59:933–7.

    Article  PubMed  CAS  Google Scholar 

  111. Pfeifer R, Jung C, Purle P, et al. Survival does not improve when therapeutic hypothermia is added to post-cardiac arrest care. Resuscitation. 2011;82:1168–73.

    Article  PubMed  Google Scholar 

  112. Piriyawat P, Morgenstern LB, Yawn DH, et al. Grotta JC. Treatment of acute intracerebral hemorrhage with epsilon-aminocaproic acid: a pilot study. Neurocrit Care. 2004;1:47–51.

    Article  PubMed  CAS  Google Scholar 

  113. Plowman RS, Clarke A, Clarke M, et al. Sixteen-year single-surgeon experience with coil embolization for ruptured intracranial aneurysms: recurrence rate and incidence of late rebleeding. J Neurosurg. 2011;114:863–74.

    Article  PubMed  Google Scholar 

  114. Prasad K, Mendelow AD, Gregson B. Surgery for primary supratentorial intracerebral hemorrhage. Cochrane Database Syst Rev. 2008;(4):CD000200.

    Google Scholar 

  115. Pratt CH. The treatment of epilepsy. Can Med Assoc J. 1928;19:303–12.

    PubMed  CAS  Google Scholar 

  116. Pritz MB, Giannotta SL, Kindt GW, et al. Treatment of patients with neurological deficits associated with cerebral vasospasm by intravascular volume expansion. Neurosurgery. 1978;3:364–8.

    Article  PubMed  CAS  Google Scholar 

  117. Rabinstein AA, Atkinson JL, Wijdicks EFM. Emergency craniotomy in patients worsening due to expanded cerebral hematoma: to what purpose? Neurology. 2002;58:1367–72.

    Article  PubMed  Google Scholar 

  118. Rabinstein AA, Mueller-Kronast N, Maramattom BV, et al. Factors predicting prognosis after decompressive hemicraniectomy for hemispheric infarction. Neurology. 2006;67:891–3.

    Article  PubMed  CAS  Google Scholar 

  119. Rabinstein AA, Wijdicks EFM. Surgery for intracerebral hematoma: the search for the elusive right candidate. Rev Neurol Dis. 2006;3:163–72.

    PubMed  Google Scholar 

  120. Rabinstein AA, Wijdicks EFM, Nichols DA. Complete recovery after early intra-arterial recombinant tissue plasminogen activator thrombolysis of carotid T occlusion. AJNR Am J Neuroradiol. 2002;23:1596–9.

    PubMed  Google Scholar 

  121. Radberg JA, Olson JE, Radberg CT. Prognostic parameters in spontaneous intracerebral hematomas with special reference to anticoagulant treatment. Stroke. 1991;22:571–6.

    Article  PubMed  CAS  Google Scholar 

  122. Ransohof J, Benjamin V, Gage L, et al.Hemicraniectomy in the management of acute subdural hematoma. J Neurosurg. 1971;34:70–6.

    Article  Google Scholar 

  123. Rinkel GJ, Feigin VL, Algra A, et al. Calcium antagonists for aneurysmal subarachnoid hemorrhage. Cochrane Database Syst Rev. 2005;(3):CD000277.

    Google Scholar 

  124. Robertson EG. Cerebral lesions due to intracranial aneurysms. Brain. 1949;72:150–85.

    Article  PubMed  CAS  Google Scholar 

  125. Robinson MT, Rabinstein AA, Meschia JF, et al. Safety of recombinant activated factor VII in patients with warfarin-associated hemorrhages of the central nervous system. Stroke. 2010;41:1459–63.

    Article  PubMed  CAS  Google Scholar 

  126. Roine RO, Kaste M, Kinnunen A, et al. Nimodipine after resuscitation from out-of-hospital ventricular fibrillation. A placebo-controlled, double-blind, randomized trial. JAMA. 1990;264:3171–7.

    Article  PubMed  CAS  Google Scholar 

  127. Roos YB, Levi M, Carroll TA, et al. Nimodipine increases fibrinolytic activity in patients with aneurysmal subarachnoid hemorrhage. Stroke. 2001;32:1860–2.

    Article  PubMed  CAS  Google Scholar 

  128. Roos YB, Rinkel G, Vermeulen M, et al. Antifibrinolytic therapy for aneurysmal subarachnoid hemorrhage. Cochrane Database Syst Rev. 2003;(2):CD001245.

    Google Scholar 

  129. Rosenwasser RH, Jallo JI, Getch CC, et al. Complications of Swan-Ganz catheterization for hemodynamic monitoring in patients with subarachnoid hemorrhage. Neurosurgery. 1995;37:872–5.

    Article  PubMed  CAS  Google Scholar 

  130. Russek HI, Zohman BL, Russek AS. Cortisone in immediate therapy of apoplectic stroke. J Am Geriatr Soc. 1954;2:216–22.

    PubMed  CAS  Google Scholar 

  131. Scarcella G. Encephalomalacia simulating the clinical and radiological aspects of brain tumor; a report of 6 cases. J Neurosurg. 1956;13:278–92.

    Article  PubMed  CAS  Google Scholar 

  132. Shanahan WT. Report of the meeting of the American association for the study and the care and treatment of epileptics. Baltimore, Maryland 25th, 1914: II. Treatment of status epilepticus. Epilepsia. 1915;5: 283–91.

    Article  Google Scholar 

  133. Shorvon S. Status epilepticus: its clinical features and treatment in children and adults. Cambridge: Cambridge University Press; 1994.

    Book  Google Scholar 

  134. Silbergleit R, Durkalski V, Lowenstein D et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J. Med. 2012:366:591–600.

    Article  PubMed  CAS  Google Scholar 

  135. Solomon RA, Fink ME, Lennihan L. Early aneurysm surgery and prophylactic hypervolemic hypertensive therapy for the treatment of aneurysmal subarachnoid hemorrhage. Neurosurgery. 1988;23:699–704.

    Article  PubMed  CAS  Google Scholar 

  136. Solomon RA, Fink ME, Lennihan L. Prophylactic volume expansion therapy for the prevention of delayed cerebral ischemia after early aneurysm surgery. Results of a preliminary trial. Arch Neurol. 1988;45:325–32.

    Article  PubMed  CAS  Google Scholar 

  137. Spiller WG, Franzier CH. Cerebral decompression. Palliative operations in the treatment of tumors of the brain, based on the observation of fourteen cases. JAMA. 1906;47:679–83.

    Article  Google Scholar 

  138. Starke RM, Connolly ES. Rebleeding after aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2011;15:241–7.

    Article  PubMed  CAS  Google Scholar 

  139. Starke RM, Kim GH, Fernandez A, et al. Impact of a policy of early antifibrinolytic therapy for the prevention of acute rebleeding after aneurysmal subarachnoid hemorrhage. Stroke. 2008;39:2617–21.

    Article  PubMed  CAS  Google Scholar 

  140. Stertz F, Safar P, Tisherman SA, et al. Mild hypothermic cardiopulmonary resuscitation improves outcome after cardiac arrest in dogs. Crit Care Med. 1991;19:379–89.

    Article  Google Scholar 

  141. Sutherland CS, Hill MD, Kaufmann AM, et al. Recombinant factor VIIa plus surgery for intracerebral hemorrhage. Can J Neurol Sci. 2008;35:567–72.

    PubMed  Google Scholar 

  142. Teernstra OPM, Evers SMAA, Lodder J, et al. Stereotactic treatment of intracerebral hematoma by means of a plasminogen activator: a multicenter randomized controlled trial (SICHPA). Stroke. 2003;34:968–74.

    Article  PubMed  CAS  Google Scholar 

  143. Tellez H, Bauer RB. Dexamethasone as treatment in acute cerebrovascular disease. I. A controlled study in intracerebral hemorrhage. Stroke. 1973;4:541–6.

    Article  PubMed  CAS  Google Scholar 

  144. The Guillain-Barré Syndrome Study Group. Plasmapheresis and acute Guillain-Barré syndrome. Neurology. 1985;35:1096–104.

    Google Scholar 

  145. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581–7.

    Google Scholar 

  146. Theron J, Courtheoux P, Casasco A, et al. Local intraarterial fibrinolysis in the carotid territory. AJNR Am J Neuroradiol. 1989;10:753–65.

    PubMed  CAS  Google Scholar 

  147. Treatment of convulsive status epilepticus. Recommendations of the Epilepsy Foundation of America’s Working Group on Status Epilepticus. JAMA. 1993;270:854–9.

    Google Scholar 

  148. Treiman DM, Meyers PD, Walton NY, et al. A comparison of four treatments for generalized convulsive status epilepticus. Veterans Affairs Status Epilepticus Cooperative Study Group. N Engl J Med. 1998;339:792–8.

    Article  PubMed  CAS  Google Scholar 

  149. Tuhrim S. Intracerebral hemorrhage – improving outcome by reducing volume? N Engl J Med. 2008;358:2174–6.

    Article  PubMed  CAS  Google Scholar 

  150. Vahedi K, Hofmeijer J, Juettler E, et al. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomized controlled trials. Lancet Neurol. 2007;6:215–22.

    Article  PubMed  Google Scholar 

  151. van Doorn PA, Kuitwaard K, Walgaard C, et al. IVIG treatment and prognosis in Guillain-Barré syndrome. J Clin Immunol. 2010;30:S74–8.

    Article  PubMed  CAS  Google Scholar 

  152. van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome. Lancet Neurol. 2008;7:939–50.

    Article  PubMed  Google Scholar 

  153. van Koningsveld R, Schmitz PI, Meché FG, et al. Effect of methylprednisolone when added to standard treatment with intravenous immunoglobulin for Guillain-Barré syndrome: randomized trial. Lancet. 2004;363:192–6.

    Article  PubMed  CAS  Google Scholar 

  154. Vermeulen M. A patient that changed my practice: the first chronic inflammatory demyelinating polyneuropathy patient to be treated with intravenous immunoglobulin. Pract Neurol. 2002;2:354–7.

    Article  Google Scholar 

  155. Vermeulen M, Muizelaar JP. Do antifibrinolytic agents prevent rebleeding after rupture of a cerebral aneurysm? A review. Clin Neurol Neurosurg. 1980;82:25–30.

    Article  PubMed  CAS  Google Scholar 

  156. Vermeulen M, van der Meché FGA, Speelman JD, et al. Busch HFM. Plasma and gamma-globulin infusion in chronic inflammatory polyneuropathy. J Neurol Sci. 1985;70:317–26.

    Article  PubMed  CAS  Google Scholar 

  157. Wada R, Aviv RI, Fox AJ, et al. CT angiography “spot sign” predicts hematoma expansion in acute intracerebral hemorrhage. Stroke. 2007;38:1257–62.

    Article  PubMed  Google Scholar 

  158. Walker MC, Smith SJ, Shorvon SD. The intensive care treatment of convulsive status epilepticus in the UK. Results of a national survey and recommendations. Anaesthesia. 1995;50:130–5.

    Article  PubMed  CAS  Google Scholar 

  159. Wallis W, Kutt H, McDowell F. Intravenous diphenyl hydantoin in the treatment of acute repetitive seizures. Neurology. 1968;18:513–25.

    Article  PubMed  CAS  Google Scholar 

  160. Wasterlain CG, Treiman DM. Status epilepticus. Mechanism and management. Boston: The MIT Press; 2006.

    Google Scholar 

  161. Wechsler LR, Jungreis CA. Intra-arterial thrombolysis for carotid circulation ischemia. Crit Care Clin. 1999;15:701–18.

    Article  PubMed  CAS  Google Scholar 

  162. Weinrauch V, Safar P, Tisherman S, et al. Cerebral benefit of mild or moderate hypothermia and cardiac risk of deep resuscitative hypothermia after cardiac arrest in dogs. Stroke. 1992;23:1454–62.

    Article  PubMed  CAS  Google Scholar 

  163. Wijdicks EFM, Diringer MN. Middle cerebral artery territory infarction and early brain swelling: progression and effect of age on outcome. Mayo Clin Proc. 1998;73:829–36.

    Article  PubMed  CAS  Google Scholar 

  164. Wijdicks EFM, Fugate J. Anoxic-ischemic encephalopathy. In: Bradley WG, Darroff RB, Fenichel GM, Jankovic J, Mazziotta J (Eds) Bradley’s Neurology in Clinical Practice. 6th ed. Philadelphia: Elsevier; 2012.

    Google Scholar 

  165. Wijdicks EFM, Hasan D, Lindsay KW, et al. Short-term tranexamic acid treatment in aneurysmal subarachnoid hemorrhage. Stroke. 1989;20:1674–9.

    Article  PubMed  CAS  Google Scholar 

  166. Wijdicks EFM, Nichols DA, Thielen KR, et al. Intra-arterial thrombolysis in acute basilar artery thromboembolism: the initial Mayo Clinic experience. Mayo Clin Proc. 1997;72:1005–13.

    Article  PubMed  CAS  Google Scholar 

  167. Wolf S, Martin H, Landscheidt JF, et al. Continuous selective intraarterial infusion of nimodipine for therapy of refractory cerebral vasospasm. Neurocrit Care. 2010;12:346–51.

    Article  PubMed  CAS  Google Scholar 

  168. Yeo JD, Stabback S, McKenzie B. Central necrosis following contusion to the sheep’s spinal cord. Paraplegia. 1977;14:276–85.

    Article  PubMed  CAS  Google Scholar 

  169. Zaganas I, Halpin AP, Oleinik A, et al. A comparison of acute hemorrhagic stroke outcomes in 2 populations: the Crete-Boston Study. Stroke. 2011;42:3640–2.

    Article  PubMed  Google Scholar 

  170. Zeumer H, Hundgen R, Ferbert A, et al. Local intra-arterial fibrinolytic therapy in inaccessible internal carotid occlusion. Neuroradiology. 1984;26:315–7.

    PubMed  CAS  Google Scholar 

  171. Zuccarello M, Brott T, Derex L, et al. Early surgical treatment for intracerebral hemorrhage. A randomized feasibility study. Stroke. 1999;30:1833–9.

    Article  PubMed  CAS  Google Scholar 

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Wijdicks, E.F.M. (2012). First Clinical Studies and Trials. In: Famous First Papers for the Neurointensivist. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-3182-4_6

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