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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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.
Highlights
The data collected during internal pilots can be used in the final substantive trial analysis, and has remained blinded, but is still helpful for informing on the design of future pilot trials[11]
Pilot trial recruitment commenced in August 2015, five months later than the original anticipated start date of March 2015 (Fig. 4)
The 100th patient was recruited within nine months of the August start date, surpassing the recruitment target rate and allowing progression onto the substantive trial which has recruited 653 patients to July 2018 (Table 5)
Summary
In a chronic subdural haematoma (CSDH), blood and fluid collect in the subdural space overlying the brain. It primarily affects elderly patients, many of whom have experienced a head trauma within the preceding weeks[1]. The UK has helped take a lead on improving research in neurosurgery, being 3rd in the world for publishing neurosurgery randomised control trials (RCT) between 2000-201412. This has been a challenge due to historically low levels of neurosurgical RCTs which can result in deficient research infrastructure, training and experience[13]. Focus on engagement of local research teams to maximise patient recruitment and retention is essential
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