Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction

Jeannette Hofmeijer, G Johan Amelink, Ale Algra, Jan van Gijn, Malcolm R Macleod, L Jaap Kappelle, H Bart van der Worp, HAMLET investigators, Jeannette Hofmeijer, G Johan Amelink, Ale Algra, Jan van Gijn, Malcolm R Macleod, L Jaap Kappelle, H Bart van der Worp, HAMLET investigators

Abstract

Background: Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction

Methods: The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

References

    1. Shaw CM, Alvord Jr EC, Berry EG. Swelling of the brain following ischemic infarction with arterial occlusion. Arch Neurol. 1959;1:161–177.
    1. Ropper AH, Shafran B. Brain edema after stroke. Clinical syndrome and intracranial pressure. Arch Neurol. 1984;41:26–29.
    1. Wardlaw JM, Dennis MS, Lindley RI, Warlow CP, Sandercock PAG, Sellar R. Does early reperfusion of a cerebral infarct influence cerebral infarct swelling in the acute stage or the final clinical outcome? Cerebrovasc Dis. 1993;3:86–93.
    1. Frank JI. Large hemispheric infarction, deterioration, and intracranial pressure [see comments] Neurology. 1995;45:1286–1290.
    1. Schwab S, Aschoff A, Spranger M, Albert F, Hacke W. The value of intracranial pressure monitoring in acute hemispheric stroke. Neurology. 1996;47:393–398.
    1. Silver FL, Norris JW, Lewis AJ, Hachinski VC. Early mortality following stroke: a prospective review. Stroke. 1984;15:492–496.
    1. Heinsius T, Bogousslavsky J, Van Melle G. Large infarcts in the middle cerebral artery territory. Etiology and outcome patterns [published erratum appears in Neurology 1998 Jun;50(6):1940-3] [see comments] Neurology. 1998;50:341–350.
    1. Biller J, Adams-HP J, Bruno A, Love BB, Marsh EE. Mortality in acute cerebral infarction in young adults--a ten-year experience. Angiology. 1991;42:224–230.
    1. Hacke W, Schwab S, Horn M, Spranger M, De Georgia M, von Kummer R. 'Malignant' middle cerebral artery territory infarction: clinical course and prognostic signs. Arch Neurol. 1996;53:309–315.
    1. Wijdicks EF, Diringer MN. Middle cerebral artery territory infarction and early brain swelling: progression and effect of age on outcome. Mayo Clin Proc. 1998;73:829–836.
    1. Adams-HP J, Brott TG, Crowell RM, Furlan AJ, Gomez CR, Grotta J, Helgason CM, Marler JR, Woolson RF, Zivin JA, et Guidelines for the management of patients with acute ischemic stroke. A statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association [see comments] Stroke. 1994;25:1901–1914.
    1. Wijdicks EF. Management of massive hemispheric cerebral infarct: is there a ray of hope? Mayo Clin Proc. 2000;75:945–952.
    1. Schwarz S, Schwab S, Bertram M, Aschoff A, Hacke W. Effects of hypertonic saline hydroxyethyl starch solution and mannitol in patients with increased intracranial pressure after stroke. Stroke. 1998;29:1550–1555.
    1. Hofmeijer J, van der Worp HB, Kappelle LJ. Treatment of space-occupying cerebral infarction. Crit Care Med. 2003;31:617–625. doi: 10.1097/01.CCM.0000050446.16158.80.
    1. Schwab S, Spranger M, Schwarz S, Hacke W. Barbiturate coma in severe hemispheric stroke: useful or obsolete? Neurology. 1997;48:1608–1613.
    1. Muizelaar JP, Marmarou A, Ward JD, Kontos HA, Choi SC, Becker DP, Gruemer H, Young HF. Adverse effects of prolonged hyperventilation in patients with severe head injury: a randomized clinical trial. J Neurosurg. 1991;75:731–739.
    1. Kaufmann AM, Cardoso ER. Aggravation of vasogenic cerebral edema by multiple-dose mannitol. J Neurosurg. 1992;77:584–589.
    1. Ropper AH. Neurological intensive care. Ann Neurol. 1992;32:564–569. doi: 10.1002/ana.410320413.
    1. Schwab S. Rieke K, Aschoff A, Albert F, von Kummer R, Hacke W. Hemicraniotomy in space-occupying hemispheric infarction: useful early intervention or desparate activism? Cerebrovasc Dis. 1996;6:325–329.
    1. Forsting M, Reith W, Schabitz WR, Heiland S, von Kummer R, Hacke W, Sartor K. Decompressive craniectomy for cerebral infarction. An experimental study in rats. Stroke. 1995;26:259–264.
    1. Doerfler A, Forsting M, Reith W, Staff C, Heiland S, Schabitz WR, von Kummer R, Hacke W, Sartor K. Decompressive craniectomy in a rat model of "malignant" cerebral hemispheric stroke: experimental support for an aggressive therapeutic approach. J Neurosurg. 1996;85:853–859.
    1. Carter BS, Ogilvy CS, Candia GJ, Rosas HD, Buonanno F. One-year outcome after decompressive surgery for massive nondominant hemispheric infarction. Neurosurgery. 1997;40:1168–1175. doi: 10.1097/00006123-199706000-00010.
    1. Koh MS, Goh KY, Tung MY, Chan C. Is decompressive craniectomy for acute cerebral infarction of any benefit? Surg Neurol. 2000;53:225–230. doi: 10.1016/S0090-3019(00)00163-4.
    1. Rieke K, Schwab S, Krieger D, von Kummer R, Aschoff A, Schuchardt V, Hacke W. Decompressive surgery in space-occupying hemispheric infarction: results of an open, prospective trial. Crit Care Med. 1995;23:1576–1587. doi: 10.1097/00003246-199509000-00019.
    1. Schwab S, Steiner T, Aschoff A, Schwarz S, Steiner HH, Jansen O, Hacke W. Early hemicraniectomy in patients with complete middle cerebral artery infarction. Stroke. 1998;29:1888–1893.
    1. Holtkamp M, Buchheim K, Unterberg A, Hoffmann O, Schielke E, Weber JR, Masuhr F. Hemicraniectomy in elderly patients with space occupying media infarction: improved survival but poor functional outcome. J Neurol Neurosurg Psychiatry. 2001;70:226–228. doi: 10.1136/jnnp.70.2.226.
    1. Gupta R, Connolly ES, Mayer S, Elkind MS. Hemicraniectomy for massive middle cerebral artery territory infarction: a systematic review. Stroke. 2004;35:539–543. doi: 10.1161/01.STR.0000109772.64650.18.
    1. Manai R, Srour A, Crozier S, Vandamme X, Samson Y, Cornu P, Rancurel G. Long-term functional outcome of hemicraniectomy in middle cerebral artery malignant infarcts [abstract] J Neurol. 2001;248 (suppl 2):121–122.
    1. Brott T, Adams HPJ, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, . Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–870.
    1. Bamford JM, Sandercock PA, Warlow CP, Slattery J. Interobserver agreement for the assessment of handicap in stroke patients [letter] Stroke. 1989;20:828.
    1. MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965;14:61–65.
    1. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–389.
    1. Indredavik B, Bakke F, Slordahl SA, Rokseth R, Haheim LL. Stroke unit treatment improves long-term quality of life: a randomized controlled trial. Stroke. 1998;29:895–899.
    1. Williams LS, Yilmaz EY, Lopez-Yunez AM. Retrospective assessment of initial stroke severity with the NIH Stroke Scale. Stroke. 2000;31:858–862.
    1. Brott T, Marler JR, Olinger CP, Adams HPJ, Tomsick T, Barsan WG, Biller J, Eberle R, Hertzberg V, Walker M. Measurements of acute cerebral infarction: lesion size by computed tomography. Stroke. 1989;20:871–875.
    1. van der Worp HB, Claus SP, Bar PR, Ramos LM, Algra A, van GJ, Kappelle LJ. Reproducibility of measurements of cerebral infarct volume on CT scans. Stroke. 2001;32:424–430.
    1. Krieger DW, Demchuk AM, Kasner SE, Jauss M, Hantson L. Early clinical and radiological predictors of fatal brain swelling in ischemic stroke. Stroke. 1999;30:287–292.
    1. Kasner SE, Demchuk AM, Berrouschot J, Schmutzhard E, Harms L, Verro P, Chalela JA, Abbur R, McGrade H, Christou I, Krieger DW. Predictors of fatal brain edema in massive hemispheric ischemic stroke. Stroke. 2001;32:2117–2123.
    1. Berrouschot J, Barthel H, von-Kummer R, Knapp WH, Hesse S, Schneider D. 99m technetium-ethyl-cysteinate-dimer single-photon emission CT can predict fatal ischemic brain edema. Stroke. 1998;29:2556–2562.
    1. Haring HP, Dilitz E, Pallua A, Hessenberger G, Kampfl A, Pfausler B, Schmutzhard E. Attenuated corticomedullary contrast: An early cerebral computed tomography sign indicating malignant middle cerebral artery infarction. A case-control study. Stroke. 1999;30:1076–1082.
    1. Oppenheim C, Samson Y, Manai R, Lalam T, Vandamme X, Crozier S, Srour A, Cornu P, Dormont D, Rancurel G, Marsault C. Prediction of malignant middle cerebral artery infarction by diffusion-weighted imaging. Stroke JID - 0235266. 2000;31:2175–2181.
    1. de Haan RJ, Limburg M, Van der Meulen JH, Jacobs HM, Aaronson NK. Quality of life after stroke. Impact of stroke type and lesion location. Stroke JID - 0235266. 1995;26:402–408.

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