PMID- 31492485
OWN - NLM
STAT- MEDLINE
DCOM- 20200731
LR  - 20200731
IS  - 1532-2653 (Electronic)
IS  - 0967-5868 (Linking)
VI  - 71
DP  - 2020 Jan
TI  - Prospective randomized placebo-controlled double-blind clinical study of adjuvant 
      dexamethasone with surgery for chronic subdural haematoma with post-operative 
      subdural drainage: Interim analysis.
PG  - 153-157
LID - S0967-5868(19)31364-5 [pii]
LID - 10.1016/j.jocn.2019.08.095 [doi]
AB  - 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.
CI  - Crown Copyright (c) 2019. Published by Elsevier Ltd. All rights reserved.
FAU - Mebberson, K
AU  - Mebberson K
AD  - Department of Neurosurgery, The Townsville Hospital, Douglas, Townsville 4810, 
      Queensland, Australia.
FAU - Colditz, M
AU  - Colditz M
AD  - Department of Neurosurgery, The Townsville Hospital, Douglas, Townsville 4810, 
      Queensland, Australia.
FAU - Marshman, L A G
AU  - Marshman LAG
AD  - Department of Neurosurgery, The Townsville Hospital, Douglas, Townsville 4810, 
      Queensland, Australia; School of Medicine and Dentistry, James Cook University, 
      Douglas, Townsville 4810, Queensland, Australia. Electronic address: 
      l.a.g.marshman@btinternet.com.
FAU - Thomas, P A W
AU  - Thomas PAW
AD  - Department of Neurosurgery, The Townsville Hospital, Douglas, Townsville 4810, 
      Queensland, Australia; School of Medicine and Dentistry, James Cook University, 
      Douglas, Townsville 4810, Queensland, Australia.
FAU - Mitchell, P S
AU  - Mitchell PS
AD  - Department of Neurosurgery, The Townsville Hospital, Douglas, Townsville 4810, 
      Queensland, Australia.
FAU - Robertson, K
AU  - Robertson K
AD  - School of Medicine and Dentistry, James Cook University, Douglas, Townsville 
      4810, Queensland, Australia; Department of Pharmacy, Medical Services Group, The 
      Townsville Hospital, Douglas, Townsville 4810, Queensland, Australia.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190903
PL  - Scotland
TA  - J Clin Neurosci
JT  - Journal of clinical neuroscience : official journal of the Neurosurgical Society 
      of Australasia
JID - 9433352
RN  - 0 (Adrenal Cortex Hormones)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Adrenal Cortex Hormones/administration & dosage/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Chemotherapy, Adjuvant/methods
MH  - Dexamethasone/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Drainage/*methods
MH  - Female
MH  - Hematoma, Subdural, Chronic/drug therapy/*surgery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/drug therapy/*surgery
MH  - Subdural Space/surgery
OTO - NOTNLM
OT  - Chronic
OT  - Dexamethasone
OT  - Morbidity
OT  - Subdural haematoma
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2019/09/08 06:00
MHDA- 2020/08/01 06:00
CRDT- 2019/09/08 06:00
PHST- 2019/08/09 00:00 [received]
PHST- 2019/08/24 00:00 [accepted]
PHST- 2019/09/08 06:00 [pubmed]
PHST- 2020/08/01 06:00 [medline]
PHST- 2019/09/08 06:00 [entrez]
AID - S0967-5868(19)31364-5 [pii]
AID - 10.1016/j.jocn.2019.08.095 [doi]
PST - ppublish
SO  - J Clin Neurosci. 2020 Jan;71:153-157. doi: 10.1016/j.jocn.2019.08.095. Epub 2019 
      Sep 3.