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)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Patients will be randomized to take either dexamethasone or a placebo. The treatment will be administered daily for up to 14 days on a tapering course, which reduces the dose over the study period. The study period lasts for 6 months. At 3 months and again at 6 months short questionnaires will be completed, either face to face, by post or via telephone, to assess level of recovery. CONDITION: Head injury ; Injury, Occupational Diseases, Poisoning PRIMARY OUTCOME: Modified Rankin Scale (mRS) at 6 months post‐randomisation SECONDARY OUTCOME: 1. Rate of cSDH‐related surgical interventions undertaken during the index admission; 2. Rate of cSDH‐related surgical interventions undertaken during subsequent admissions; 3. Glasgow Coma Scale (GCS) at discharge from NSU and 6 months; 4. mRS score at discharge from NSU and 3 months; 5. Barthel Index at discharge from NSU, 3 months and 6 months; 6. Mortality (30‐day and 6 months) INCLUSION CRITERIA: 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)
Epistemonikos ID: 7b1e639ba253fbf8fc6ab9c1d9c9d54081181412
First added on: Aug 23, 2024