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. 2019 Apr 10;9(1):5885.
doi: 10.1038/s41598-019-42087-z.

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

Ellie Edlmann  1   2 , Eric P Thelin  3   4 , Karen Caldwell  5 , Carole Turner  5 , Peter Whitfield  6 , Diederik Bulters  7 , Patrick Holton  7 , Nigel Suttner  8 , Kevin Owusu-Agyemang  8 , Yahia Z Al-Tamimi  9 , Daniel Gatt  9 , Simon Thomson  10 , Ian A Anderson  10 , Oliver Richards  10 , Monica Gherle  6 , Emma Toman  11 , Dipankar Nandi  12 , Phillip Kane  13 , Beatrice Pantaleo  14 , Carol Davis-Wilkie  14 , Silvia Tarantino  5 , Garry Barton  15 , Hani J Marcus  12 , Aswin Chari  16 , Antonio Belli  17 , Simon Bond  14   18 , Rafael Gafoor  14 , Sarah Dawson  14   18 , Lynne Whitehead  19 , Paul Brennan  20 , Ian Wilkinson  14 , Angelos G Kolias  3   5 , Peter J A Hutchinson  3   5 ; Dex-CSDH trial collaborative and BNTRC collaborative.
Collaborators, Affiliations

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

Ellie Edlmann et al. Sci Rep. .

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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
relevant methodological considerations in a pilot trial.
Figure 2
Figure 2
modified Rankin Scale. Category 6 added to allow for mortality outcomes.
Figure 3
Figure 3
formal progression criteria for Dex-CSDH pilot trial.
Figure 4
Figure 4
Recruitment curve. Orange line = original planned recruitment curve, Green line = same original recruitment curve pushed back 5 moths due to delay start. Blue line = actual recruitment.
Figure 5
Figure 5
blinded mRS scores from pre-morbid state to final 6-month outcome for all data entered on pilot patients at interim analysis on 5th Dec 2016. X-axis; outcome time-point, Y-axis; percentage of patients. The colours represent mRS scores as per the key.
See this image and copyright information in PMC

References

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