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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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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.

SUBMITTER: Edlmann E 

PROVIDER: S-EPMC6458174 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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

Edlmann Ellie E   Thelin Eric P EP   Caldwell Karen K   Turner Carole C   Whitfield Peter P   Bulters Diederik D   Holton Patrick P   Suttner Nigel N   Owusu-Agyemang Kevin K   Al-Tamimi Yahia Z YZ   Gatt Daniel D   Thomson Simon S   Anderson Ian A IA   Richards Oliver O   Gherle Monica M   Toman Emma E   Nandi Dipankar D   Kane Phillip P   Pantaleo Beatrice B   Davis-Wilkie Carol C   Tarantino Silvia S   Barton Garry G   Marcus Hani J HJ   Chari Aswin A   Belli Antonio A   Bond Simon S   Gafoor Rafael R   Dawson Sarah S   Whitehead Lynne L   Brennan Paul P   Wilkinson Ian I   Kolias Angelos G AG   Hutchinson Peter J A PJA  

Scientific reports 20190410 1


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  ...[more]

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