Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase

Abstract

The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.

Trial of Dexamethasone for Chronic Subdural Hematoma

“…An internal pilot randomized trial, which enrolled 100 patients at seven trial sites, confirmed the operational feasibility of the overall trial. 11 As prespecified, the pilot phase did not aim to assess efficacy or reestimate the sample size, and these patients were included in the final analysis.…”

Effectiveness of tranexamic acid on chronic subdural hematoma recurrence: a meta-analysis and systematic review

“…In addition, in the hematoma of patients with CSDH, the activation of plasmin's leads to a significant increase in thrombosis regulatory protein, and then forms a state of high fibrinolysis, which promotes blood vessel leakage leading to promote CSDH progression (36). Based on the understanding of inflammation, angiogenesis, and hyperfibrinolysis in the development of CSDH, Several related studies have investigated the role of various medical adjuncts, such as atorvastatin (37,38), dexamethasone (15,39,40), TXA (4,12,14,18,20,(40)(41)(42)(43), etc. in reducing their postoperative recurrence rate.…”

The Role of Dexamethasone in the Era of “Dex-CSDH” Randomized Controlled Trial. A Multicenter, Prospective Study on Specific Subset of Patients with Chronic Subdural Hematoma (CSDH) Treated with Dexamethasone Alone or Surgery

“…This was achieved with acceptable adverse effects related to considerable period of glucocorticoid therapy with strict vigilance of patient during this therapy. When pilot study on Dex-CSDH was published in 2019 with its inception in 2015 [16], the author was enthusiastically propelled to contemplate similar study in the country of his medical practice. The author wanted to conduct a randomized controlled trial comparing the efficacy and safety of Dexamethasone therapy with surgical drain of subdural collection.…”