A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma (Dex-CSDH trial)

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 sites748 target enrollmentAugust 7, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Enrollment: 748
Status: Completed
Last Updated: 5 years ago

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30514400 2. 2019 statistical analysis plan in ncbi.nlm.nih.gov/pubmed/31822298 (added 12/12/2019) 3. 2020 results in https://pubmed.ncbi.nlm.nih.gov/33326713/ (added 17/12/2020)

Registry

who.int

Start Date

August 7, 2015

End Date

August 29, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

•1\. Informed consent
•2\. Adults aged 16 or older
•3\. Symptomatic cSDH confirmed on cranial imaging (predominantly hypodense or isodense crescentic collection along the cerebral convexity on CT)

•1\. Patients who have already undergone surgical intervention for a cSDH during the same index admission
•2\. Condition with conditions where steroids are clearly contra\-indicated (i.e. active infections)
•3\. Already on steroids
•4\. Enrolment in same study within last 12 months
•5\. Time interval from the time of admission to NSU to initiation of trial medication exceeds 72 hours
•6\. cSDH in presence of CSF shunt