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

Dex-CSDH trial collaborative and BNTRC collaborative, Ellie Edlmann (Lead / Corresponding author), Eric P. Thelin, Karen Caldwell, Carole Turner, Peter Whitfield, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z. Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A. Anderson, Oliver Richards, Monica Gherle, Emma Toman, Dipankar Nandi, Phillip Kane, Beatrice PantaleoCarol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J. Marcus, Aswin Chari, Antonio Belli, Simon Bond, Rafael Gafoor, Sarah Dawson, Lynne Whitehead, Paul Brennan, Ian Wilkinson, Angelos G. Kolias, Peter J. A. Hutchinson

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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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

Original languageEnglish
Article number5885
Pages (from-to)1-13
Number of pages13
JournalScientific Reports
Volume9
DOIs
Publication statusPublished - 10 Apr 2019

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Hematoma, Subdural, Chronic
Dexamethasone
Randomized Controlled Trials
Placebos
Outcome Assessment (Health Care)
Clinical Trials Data Monitoring Committees
Safety
Ethics Committees
Pharmaceutical Preparations

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Dex-CSDH trial collaborative and BNTRC collaborative, Edlmann, E., Thelin, E. P., Caldwell, K., Turner, C., Whitfield, P., ... Hutchinson, P. J. A. (2019). Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase. Scientific Reports, 9, 1-13. [5885]. https://doi.org/10.1038/s41598-019-42087-z
Dex-CSDH trial collaborative and BNTRC collaborative ; Edlmann, Ellie ; Thelin, Eric P. ; Caldwell, Karen ; Turner, Carole ; Whitfield, Peter ; Bulters, Diederik ; Holton, Patrick ; Suttner, Nigel ; Owusu-Agyemang, Kevin ; Al-Tamimi, Yahia Z. ; Gatt, Daniel ; Thomson, Simon ; Anderson, Ian A. ; Richards, Oliver ; Gherle, Monica ; Toman, Emma ; Nandi, Dipankar ; Kane, Phillip ; Pantaleo, Beatrice ; Davis-Wilkie, Carol ; Tarantino, Silvia ; Barton, Garry ; Marcus, Hani J. ; Chari, Aswin ; Belli, Antonio ; Bond, Simon ; Gafoor, Rafael ; Dawson, Sarah ; Whitehead, Lynne ; Brennan, Paul ; Wilkinson, Ian ; Kolias, Angelos G. ; Hutchinson, Peter J. A. / Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma : report of the internal pilot phase. In: Scientific Reports. 2019 ; Vol. 9. pp. 1-13.
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Dex-CSDH trial collaborative and BNTRC collaborative, Edlmann, E, Thelin, EP, Caldwell, K, Turner, C, Whitfield, P, Bulters, D, Holton, P, Suttner, N, Owusu-Agyemang, K, Al-Tamimi, YZ, Gatt, D, Thomson, S, Anderson, IA, Richards, O, Gherle, M, Toman, E, Nandi, D, Kane, P, Pantaleo, B, Davis-Wilkie, C, Tarantino, S, Barton, G, Marcus, HJ, Chari, A, Belli, A, Bond, S, Gafoor, R, Dawson, S, Whitehead, L, Brennan, P, Wilkinson, I, Kolias, AG & Hutchinson, PJA 2019, 'Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase', Scientific Reports, vol. 9, 5885, pp. 1-13. https://doi.org/10.1038/s41598-019-42087-z

Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma : report of the internal pilot phase. / Dex-CSDH trial collaborative and BNTRC collaborative; Edlmann, Ellie (Lead / Corresponding author); Thelin, Eric P.; Caldwell, Karen; Turner, Carole; Whitfield, Peter; Bulters, Diederik; Holton, Patrick; Suttner, Nigel; Owusu-Agyemang, Kevin; Al-Tamimi, Yahia Z.; Gatt, Daniel; Thomson, Simon; Anderson, Ian A.; Richards, Oliver; Gherle, Monica; Toman, Emma; Nandi, Dipankar; Kane, Phillip; Pantaleo, Beatrice; Davis-Wilkie, Carol; Tarantino, Silvia; Barton, Garry; Marcus, Hani J.; Chari, Aswin; Belli, Antonio; Bond, Simon; Gafoor, Rafael; Dawson, Sarah; Whitehead, Lynne; Brennan, Paul; Wilkinson, Ian; Kolias, Angelos G.; Hutchinson, Peter J. A.

In: Scientific Reports, Vol. 9, 5885, 10.04.2019, p. 1-13.

Research output: Contribution to journalArticle

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T1 - Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma

T2 - report of the internal pilot phase

AU - Dex-CSDH trial collaborative and BNTRC collaborative

AU - Edlmann, Ellie

AU - Thelin, Eric P.

AU - Caldwell, Karen

AU - Turner, Carole

AU - Whitfield, Peter

AU - Bulters, Diederik

AU - Holton, Patrick

AU - Suttner, Nigel

AU - Owusu-Agyemang, Kevin

AU - Al-Tamimi, Yahia Z.

AU - Gatt, Daniel

AU - Thomson, Simon

AU - Anderson, Ian A.

AU - Richards, Oliver

AU - Gherle, Monica

AU - Toman, Emma

AU - Nandi, Dipankar

AU - Kane, Phillip

AU - Pantaleo, Beatrice

AU - Davis-Wilkie, Carol

AU - Tarantino, Silvia

AU - Barton, Garry

AU - Marcus, Hani J.

AU - Chari, Aswin

AU - Belli, Antonio

AU - Bond, Simon

AU - Gafoor, Rafael

AU - Dawson, Sarah

AU - Whitehead, Lynne

AU - Brennan, Paul

AU - Wilkinson, Ian

AU - Kolias, Angelos G.

AU - Hutchinson, Peter J. A.

AU - Badran, Khaled

AU - Coulter, Ian

AU - Gallagher, Mathew J.

AU - Hogg, Florence R.A.

AU - Pringle, Catherine

AU - Razak, Adam

AU - Soleiman, Hamzah

AU - Piper, Rory

AU - Vintu, Marian

AU - Wahba, Adam

AU - Wiggins, Anthony

AU - Yakoub, Kamal Makram

AU - Zaben, Malik

AU - Zolnourian, Ardalan

AU - Bodkin, Peter

AU - Cirstea, Emanuel

AU - Hossain-Ibrahim, Kismet

PY - 2019/4/10

Y1 - 2019/4/10

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AB - 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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Dex-CSDH trial collaborative and BNTRC collaborative, Edlmann E, Thelin EP, Caldwell K, Turner C, Whitfield P et al. Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase. Scientific Reports. 2019 Apr 10;9:1-13. 5885. https://doi.org/10.1038/s41598-019-42087-z