Prospective randomized placebo-controlled double-blind clinical study of adjuvant dexamethasone with surgery for chronic subdural haematoma with post-operative subdural drainage: Interim analysis

J Clin Neurosci. 2020 Jan:71:153-157. doi: 10.1016/j.jocn.2019.08.095. Epub 2019 Sep 3.

Abstract

Most chronic subdural haematomas (CSDH) are successfully treated neurosurgically. However, operative recurrences occur with a frequency 3-30%, consume resources and potentially prolong length-of stay (LOS). The only adjuvant factor proven to significantly decrease CSDH recurrence rate (RR) is post-operative subdural drainage. Corticosteroids have been used to conservatively manage CSDH. One non-randomised study also compared dexamethasone (DX) as an adjunct to surgery without post-operative drainage: whilst a null effect was observed, the 'surgery-alone' group consisted of only n = 13. We present an interim analysis of the first registered prospective randomised placebo-controlled trial (PRPCT) of adjuvant DX on RR and outcome after CSDH surgery with post-operative drainage. Participants were randomised to either placebo or a reducing DX regime over 2 weeks, with CSDH evacuation and post-operative drainage. Post-operative mortality (POMT) and RR were determined at 30 days and 6 months; modified Rankin Score (mRS) at discharge and 6 months. Post-operative morbidity (POMB) and adverse events (AEs) were determined at 30 days. Interim analysis at approximately 50% estimated sample size was performed (n = 47). Recurrences were not observed with DX: only with placebo (0/23 [0%] v 5/24 [20.83%], P = 0.049). There was no significant between-group differences in POMT, POMB, LOS, mRS or AEs. CONCLUSIONS: In this first registered PRPCT, interim analysis suggested that adjuvant DX with post-operative drainage is both safe and may significantly decrease recurrences. A 12.5% point between-groups difference may be reasonable to power a final sample size of approximately n = 89. Future studies could consider adjuvant DX for longer than the arbitrarily-chosen 2 weeks.

Keywords: Chronic; Dexamethasone; Morbidity; Subdural haematoma.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage
  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Aged
  • Chemotherapy, Adjuvant / methods
  • Dexamethasone / administration & dosage
  • Dexamethasone / therapeutic use*
  • Double-Blind Method
  • Drainage / methods*
  • Female
  • Hematoma, Subdural, Chronic / drug therapy
  • Hematoma, Subdural, Chronic / surgery*
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / drug therapy
  • Postoperative Complications / surgery*
  • Subdural Space / surgery

Substances

  • Adrenal Cortex Hormones
  • Dexamethasone