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Trial of Dexamethasone for Chronic Subdural Hematoma
Peter J Hutchinson1, Ellie Edlmann1, Diederik Bulters1
1From the Divisions of Neurosurgery (P.J.H., E.E., E.P.T., S. Tarantino, K.C., H.M., T.S., C.T., A.G.K.) and Neurology (E.A.W.), Department of Clinical Neurosciences, and the Division of Experimental Medicine and Immunotherapeutics (I.W.), Addenbrooke's Hospital, University of Cambridge, and the Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust (A.A., B.P., C.D.-W., I.W., S.B.), Cambridge, the Faculty of Health: Medicine, Dentistry and Human Sciences, University of Plymouth (E.E.), and the South West Neurosurgical Centre, Derriford Hospital (E.E., P.C.W., M.G.), Plymouth, Wessex Neurological Unit, University Hospital Southampton, Southampton (D.B., A.Z., P.H.), the Department of Neurosurgery, Queen Elizabeth University Hospital, Glasgow (N.S., K.A.), the Department of Neurosurgery, Leeds General Infirmary, Leeds (S. Thomson, I.A.A.), the Department of Neurosurgery, Royal Hallamshire Hospital, Sheffield (Y.Z.A.-T., D.H.), Translational Neurosurgery, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh (P.M.B.), Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich (G.B.), the Department of Neurosurgery, Great Ormond Street Hospital and Institute of Child Health, University College London (A.C.), and the National Hospital for Neurology and Neurosurgery (H.J.M.), London, the Department of Neurosurgery, Manchester Centre for Clinical Neurosciences, Salford Royal Hospital, Manchester Academic Health Science Centre, Manchester (A.T.K.), the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre and Institute of Inflammation and Ageing, University of Birmingham, Birmingham (A.B.), and the Ageing Clinical and Experimental Research Group, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen (P.K.M.) - all in the United Kingdom; and the Department of Neurology, Karolinska University Hospital, Stockholm (E.P.T.).
Background:
Chronic subdural hematoma is a common neurologic disorder that is especially prevalent among older people. The effect of dexamethasone on outcomes in patients with chronic subdural hematoma has not been well studied.
Methods:
We conducted a multicenter, randomized trial in the United Kingdom that enrolled adult patients with symptomatic chronic subdural hematoma. The patients were assigned in a 1:1 ratio to receive a 2-week tapering course of oral dexamethasone, starting at 8 mg twice daily, or placebo. The decision to surgically evacuate the hematoma was made by the treating clinician. The primary outcome was a score of 0 to 3, representing a favorable outcome, on the modified Rankin scale at 6 months after randomization; scores range from 0 (no symptoms) to 6 (death).
Results:
From August 2015 through November 2019, a total of 748 patients were included in the trial after randomization - 375 were assigned to the dexamethasone group and 373 to the placebo group. The mean age of the patients was 74 years, and 94% underwent surgery to evacuate their hematomas during the index admission; 60% in both groups had a score of 1 to 3 on the modified Rankin scale at admission. In a modified intention-to-treat analysis that excluded the patients who withdrew consent for participation in the trial or who were lost to follow-up, leaving a total of 680 patients, a favorable outcome was reported in 286 of 341 patients (83.9%) in the dexamethasone group and in 306 of 339 patients (90.3%) in the placebo group (difference, -6.4 percentage points [95% confidence interval, -11.4 to -1.4] in favor of the placebo group; P = 0.01). Among the patients with available data, repeat surgery for recurrence of the hematoma was performed in 6 of 349 patients (1.7%) in the dexamethasone group and in 25 of 350 patients (7.1%) in the placebo group. More adverse events occurred in the dexamethasone group than in the placebo group.
Conclusions:
Among adults with symptomatic chronic subdural hematoma, most of whom had undergone surgery to remove their hematomas during the index admission, treatment with dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo at 6 months, but fewer repeat operations were performed in the dexamethasone group. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Dex-CSDH ISRCTN number, ISRCTN80782810.).
