Abstract
Background:
Chronic subdural hematoma is a common neurological disorder, especially prevalent among older people. The effect of dexamethasone on the outcome of patients with chronic subdural hematoma has not been well studied.
Methods:
From 2015 through 2019 we randomly assigned adult patients in the U.K. with symptomatic chronic subdural hematoma in a 1:1 ratio to receive a two-week tapering course of oral dexamethasone starting at 8 mg orally twice daily, or placebo. The decision to surgically evacuate the hematoma was made by treating clinicians. The primary outcome was the difference between the two groups in the modified Rankin Scale dichotomized as a score of 0 to 3, representing favorable outcome (mRS, range 0 [no symptoms at all] to 6 [death]) at 6 months.
Results:
A total of 748 patients were included in the trial, 375 assigned to receive dexamethasone and 373 to receive placebo. The mean age of patients was 74 years and 94% had surgical treatment of their hematomas; 60% in both groups had mRS 1-3 on admission. In a modified intention to treat analysis, favorable outcome of mRS 0-3 occurred in 286/341 (83.9%) of patients receiving dexamethasone compared to 306/339 (90.3%) receiving placebo (difference, 6.4 percentage points favoring placebo; 95% confidence interval [CI] -11.4% to -1.4%; P=0.01). Repeat surgery for recurrence of the hematoma occurred in 25/350 (7.1%) in the placebo arm versus 6/349 (1.7%) in the dexamethasone arm, for whom data were available. The dexamethasone group had more adverse events.
Conclusions:
In adults with symptomatic chronic subdural hematoma, most of whom had surgical treatment of the hematoma, dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo but fewer repeat surgeries at 6 months.
Chronic subdural hematoma is a common neurological disorder, especially prevalent among older people. The effect of dexamethasone on the outcome of patients with chronic subdural hematoma has not been well studied.
Methods:
From 2015 through 2019 we randomly assigned adult patients in the U.K. with symptomatic chronic subdural hematoma in a 1:1 ratio to receive a two-week tapering course of oral dexamethasone starting at 8 mg orally twice daily, or placebo. The decision to surgically evacuate the hematoma was made by treating clinicians. The primary outcome was the difference between the two groups in the modified Rankin Scale dichotomized as a score of 0 to 3, representing favorable outcome (mRS, range 0 [no symptoms at all] to 6 [death]) at 6 months.
Results:
A total of 748 patients were included in the trial, 375 assigned to receive dexamethasone and 373 to receive placebo. The mean age of patients was 74 years and 94% had surgical treatment of their hematomas; 60% in both groups had mRS 1-3 on admission. In a modified intention to treat analysis, favorable outcome of mRS 0-3 occurred in 286/341 (83.9%) of patients receiving dexamethasone compared to 306/339 (90.3%) receiving placebo (difference, 6.4 percentage points favoring placebo; 95% confidence interval [CI] -11.4% to -1.4%; P=0.01). Repeat surgery for recurrence of the hematoma occurred in 25/350 (7.1%) in the placebo arm versus 6/349 (1.7%) in the dexamethasone arm, for whom data were available. The dexamethasone group had more adverse events.
Conclusions:
In adults with symptomatic chronic subdural hematoma, most of whom had surgical treatment of the hematoma, dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo but fewer repeat surgeries at 6 months.
| Original language | English |
|---|---|
| Pages (from-to) | 2616-2627 |
| Number of pages | 12 |
| Journal | The New England Journal of Medicine |
| Volume | 383 |
| Early online date | 16 Dec 2020 |
| DOIs | |
| Publication status | Published - 31 Dec 2020 |
Bibliographical note
(Trial funded by NIHR, Dex-CSDH Current Controlled Trials number ISRCTN80782810).ACKNOWLEDGEMENTS
In memory of Mrs. Kate Massey, who was the patient representative involved in study design. Peter Hutchinson is supported by a Research Professorship and Senior Investigator Award from the NIHR, the NIHR Cambridge Biomedical Research Centre, and the Royal College of Surgeons of England. Ellie Edlmann is supported by the Royal College of Surgeons of England. Angelos Kolias is supported by a Lectureship, School of Clinical Medicine, University of Cambridge and the Royal College of Surgeons of England.
SUPPORT
This paper presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Keywords
- Neurology
- neurosurgery
- brain injuries
- intracranial hematoma
- randomized controlled trial