Summary
Background
Chronic subdural hematoma is a common neurologic disorder that is particularly common in the elderly. The effect of dexamethasone on outcomes in patients with malignant subdural hematoma has not been well studied.
Ways
We conducted a multifunctional, randomized trial in the United Kingdom that enrolled adult patients with a typical malignant subdural hematoma. Patients were assigned 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 empty the hematoma by surgery was made by the treating clinician. The main outcome was a score of 0 to 3, representing a favorable outcome, on the Rankin modified scale at 6 months postpartum; scores range from 0 (no marks) to 6 (death).
Results
As of August 2015 through November 2019, 748 patients were admitted to the trial after randomization – 375 were given to the dexamethasone group and 373 to the placebo group. The average age of the patients was 74 years, and 94% underwent surgery to have their hematomas emptied at the time of admission to the index; 60% in each group received a score of 1 to 3 on the modified Rankin scale at admission. In a modified study of intention-to-treat patients who withdrew consent to participate in the trial or subsequently missed out, leaving a total of 680 patients, a favorable outcome was reported. the 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 the available data, hematoma recurrence surgery 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 a typical malignant subdural hematoma, most of whom underwent surgery to have their hematomas removed at the time of admission to the index, treatment with dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo at 6 months, but fewer reactions occurred in the dexamethasone group. (Funded by the National Institute for Health Research Health Technology Assessment Program; ISRCTN Dex-CSDH number, ISRCTN80782810.)