Peter J Hutchinson1, Angelos G Kolias1, Ivan S Timofeev1, Elizabeth A Corteen1, Marek Czosnyka1, Jake Timothy1, Ian Anderson1, Diederik O Bulters1, Antonio Belli1, C Andrew Eynon1, John Wadley1, A David Mendelow1, Patrick M Mitchell1, Mark H Wilson1, Giles Critchley1, Juan Sahuquillo1, Andreas Unterberg1, Franco Servadei1, Graham M Teasdale1, John D Pickard1, David K Menon1, Gordon D Murray1, Peter J Kirkpatrick1. 1. From the Division of Neurosurgery, Department of Clinical Neurosciences (P.J.H., A.G.K., I.S.T., E.A.C., M.C., J.D.P., P.J.K.), and the Division of Anaesthesia (D.K.M.), Addenbrooke's Hospital and University of Cambridge, Cambridge, the Department of Neurosurgery, Leeds General Infirmary, Leeds (J.T., I.A.), the Department of Neurosurgery (D.O.B.) and Neurosciences Intensive Care Unit (C.A.E.), Wessex Neurological Centre, University Hospital Southampton, Southampton, the NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham (A.B.), the Department of Neurosurgery, St. Bartholomew's and Royal London Hospital (J.W.), and the Department of Neurosurgery, St. Mary's Hospital (M.H.W.), London, the Institute of Neuroscience, Neurosurgical Trials Group, Newcastle University (A.D.M.), and the Department of Neurosurgery, Royal Victoria Infirmary (P.M.M.), Newcastle upon Tyne, Hurstwood Park Neurosciences Centre, Brighton and Sussex University Hospitals, Haywards Heath (G.C.), the Institute of Health and Wellbeing, University of Glasgow, Glasgow (G.M.T.), and Usher Institute of Population Health Sciences and Informatics, University of Edinburgh Medical School, University of Edinburgh, Edinburgh (G.D.M.) - all in the United Kingdom; the Department of Neurosurgery, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona (J.S.); the Department of Neurosurgery, University of Heidelberg, Heidelberg, Germany (A.U.); and the Neurosurgery-Neurotraumatology Unit, Azienda Ospedaliero-Universitaria di Parma, Arcispedale S. Maria Nuova-IRCCS Reggio Emilia, University of Parma, Parma, Italy (F.S.).
Abstract
BACKGROUND: The effect of decompressive craniectomy on clinical outcomes in patients with refractory traumatic intracranial hypertension remains unclear. METHODS:From 2004 through 2014, we randomly assigned 408 patients, 10 to 65 years of age, with traumatic brain injury and refractory elevated intracranial pressure (>25 mm Hg) to undergodecompressive craniectomy or receive ongoing medical care. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOS-E) (an 8-point scale, ranging from death to "upper good recovery" [no injury-related problems]) at 6 months. The primary-outcome measure was analyzed with an ordinal method based on the proportional-odds model. If the model was rejected, that would indicate a significant difference in the GOS-E distribution, and results would be reported descriptively. RESULTS: The GOS-E distribution differed between the two groups (P<0.001). The proportional-odds assumption was rejected, and therefore results are reported descriptively. At 6 months, the GOS-E distributions were as follows: death, 26.9% among 201 patients in the surgical group versus 48.9% among 188 patients in the medical group; vegetative state, 8.5% versus 2.1%; lower severe disability (dependent on others for care), 21.9% versus 14.4%; upper severe disability (independent at home), 15.4% versus 8.0%; moderate disability, 23.4% versus 19.7%; and good recovery, 4.0% versus 6.9%. At 12 months, the GOS-E distributions were as follows: death, 30.4% among 194 surgical patients versus 52.0% among 179 medical patients; vegetative state, 6.2% versus 1.7%; lower severe disability, 18.0% versus 14.0%; upper severe disability, 13.4% versus 3.9%; moderate disability, 22.2% versus 20.1%; and good recovery, 9.8% versus 8.4%. Surgical patients had fewer hours than medical patients with intracranial pressure above 25 mm Hg after randomization (median, 5.0 vs. 17.0 hours; P<0.001) but had a higher rate of adverse events (16.3% vs. 9.2%, P=0.03). CONCLUSIONS: At 6 months, decompressive craniectomy in patients with traumatic brain injury and refractory intracranial hypertension resulted in lower mortality and higher rates of vegetative state, lower severe disability, and upper severe disability than medical care. The rates of moderate disability and good recovery were similar in the two groups. (Funded by the Medical Research Council and others; RESCUEicp Current Controlled Trials number, ISRCTN66202560 .).
RCT Entities:
BACKGROUND: The effect of decompressive craniectomy on clinical outcomes in patients with refractory traumatic intracranial hypertension remains unclear. METHODS: From 2004 through 2014, we randomly assigned 408 patients, 10 to 65 years of age, with traumatic brain injury and refractory elevated intracranial pressure (>25 mm Hg) to undergo decompressive craniectomy or receive ongoing medical care. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOS-E) (an 8-point scale, ranging from death to "upper good recovery" [no injury-related problems]) at 6 months. The primary-outcome measure was analyzed with an ordinal method based on the proportional-odds model. If the model was rejected, that would indicate a significant difference in the GOS-E distribution, and results would be reported descriptively. RESULTS: The GOS-E distribution differed between the two groups (P<0.001). The proportional-odds assumption was rejected, and therefore results are reported descriptively. At 6 months, the GOS-E distributions were as follows: death, 26.9% among 201 patients in the surgical group versus 48.9% among 188 patients in the medical group; vegetative state, 8.5% versus 2.1%; lower severe disability (dependent on others for care), 21.9% versus 14.4%; upper severe disability (independent at home), 15.4% versus 8.0%; moderate disability, 23.4% versus 19.7%; and good recovery, 4.0% versus 6.9%. At 12 months, the GOS-E distributions were as follows: death, 30.4% among 194 surgical patients versus 52.0% among 179 medical patients; vegetative state, 6.2% versus 1.7%; lower severe disability, 18.0% versus 14.0%; upper severe disability, 13.4% versus 3.9%; moderate disability, 22.2% versus 20.1%; and good recovery, 9.8% versus 8.4%. Surgical patients had fewer hours than medical patients with intracranial pressure above 25 mm Hg after randomization (median, 5.0 vs. 17.0 hours; P<0.001) but had a higher rate of adverse events (16.3% vs. 9.2%, P=0.03). CONCLUSIONS: At 6 months, decompressive craniectomy in patients with traumatic brain injury and refractory intracranial hypertension resulted in lower mortality and higher rates of vegetative state, lower severe disability, and upper severe disability than medical care. The rates of moderate disability and good recovery were similar in the two groups. (Funded by the Medical Research Council and others; RESCUEicp Current Controlled Trials number, ISRCTN66202560 .).
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