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dc.contributor.authorHutchinson, PJ
dc.contributor.authorEdlmann, E
dc.contributor.authorBulters, D
dc.contributor.authorZolnourian, A
dc.contributor.authorHolton, P
dc.contributor.authorSuttner, N
dc.contributor.authorAgyemang, K
dc.contributor.authorThomson, S
dc.contributor.authorAnderson, IA
dc.contributor.authorAl-Tamimi, YZ
dc.contributor.authorHenderson, D
dc.contributor.authorWhitfield, PC
dc.contributor.authorGherle, M
dc.contributor.authorBrennan, PM
dc.contributor.authorAllison, A
dc.contributor.authorThelin, EP
dc.contributor.authorTarantino, S
dc.contributor.authorPantaleo, B
dc.contributor.authorCaldwell, K
dc.contributor.authorDavis-Wilkie, C
dc.contributor.authorMee, H
dc.contributor.authorWarburton, EA
dc.contributor.authorBarton, G
dc.contributor.authorChari, A
dc.contributor.authorMarcus, HJ
dc.contributor.authorKing, AT
dc.contributor.authorBelli, A
dc.contributor.authorMyint, PK
dc.contributor.authorWilkinson, I
dc.contributor.authorSantarius, T
dc.contributor.authorTurner, C
dc.contributor.authorBond, S
dc.contributor.authorKolias, AG

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.).

dc.publisherMassachusetts Medical Society
dc.subjectAdministration, Oral
dc.subjectCombined Modality Therapy
dc.subjectDisabled Persons
dc.subjectHematoma, Subdural, Chronic
dc.subjectIntention to Treat Analysis
dc.subjectMiddle Aged
dc.subjectSeverity of Illness Index
dc.subjectTreatment Outcome
dc.titleTrial of Dexamethasone for Chronic Subdural Hematoma
plymouth.journalNew England Journal of Medicine
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/FoH - Applied Parkinson's Research
plymouth.organisational-group/Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR)
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
plymouth.organisational-group/Plymouth/Users by role/Researchers in ResearchFish submission
dc.publisher.placeUnited States
dc.rights.embargoperiodNot known
rioxxterms.funderNational Institute for Health Research
rioxxterms.identifier.projectNIHR Clinical Lectureship
rioxxterms.typeJournal Article/Review
plymouth.funderNIHR Clinical Lectureship::National Institute for Health Research

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