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; 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 Pantaleo; Carol 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

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

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 language	English
Article number	5885
Pages (from-to)	1-13
Number of pages	13
Journal	Scientific Reports
Volume	9
DOIs	https://doi.org/10.1038/s41598-019-42087-z
Publication status	Published - 10 Apr 2019

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Dex-CSDH trial collaborative and BNTRC collaborative, Edlmann, E., Thelin, E. P., Caldwell, K., Turner, C., Whitfield, P., Bulters, D., Holton, P., Suttner, N., Owusu-Agyemang, K., Al-Tamimi, Y. Z., Gatt, D., Thomson, S., Anderson, I. A., Richards, O., Gherle, M., Toman, E., Nandi, D., Kane, 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. Article 5885. https://doi.org/10.1038/s41598-019-42087-z

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title = "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.",

author = "{Dex-CSDH trial collaborative and BNTRC collaborative} and Ellie Edlmann and Thelin, {Eric P.} and Karen Caldwell and Carole Turner and Peter Whitfield and Diederik Bulters and Patrick Holton and Nigel Suttner and Kevin Owusu-Agyemang and Al-Tamimi, {Yahia Z.} and Daniel Gatt and Simon Thomson and Anderson, {Ian A.} and Oliver Richards and Monica Gherle and Emma Toman and Dipankar Nandi and Phillip Kane and Beatrice Pantaleo and Carol Davis-Wilkie and Silvia Tarantino and Garry Barton and Marcus, {Hani J.} and Aswin Chari and Antonio Belli and Simon Bond and Rafael Gafoor and Sarah Dawson and Lynne Whitehead and Paul Brennan and Ian Wilkinson and Kolias, {Angelos G.} and Hutchinson, {Peter J. A.} and Khaled Badran and Ian Coulter and Gallagher, {Mathew J.} and Hogg, {Florence R.A.} and Catherine Pringle and Adam Razak and Hamzah Soleiman and Rory Piper and Marian Vintu and Adam Wahba and Anthony Wiggins and Yakoub, {Kamal Makram} and Malik Zaben and Ardalan Zolnourian and Peter Bodkin and Emanuel Cirstea and Kismet Hossain-Ibrahim",

year = "2019",

month = apr,

day = "10",

doi = "10.1038/s41598-019-42087-z",

language = "English",

volume = "9",

pages = "1--13",

journal = "Scientific Reports",

issn = "2045-2322",

publisher = "Nature Research",

}

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

Research output: Contribution to journal › Article › peer-review

TY - JOUR

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

N2 - 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.

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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U2 - 10.1038/s41598-019-42087-z

DO - 10.1038/s41598-019-42087-z

M3 - Article

C2 - 30971773

AN - SCOPUS:85064252691

SN - 2045-2322

VL - 9

SP - 1

EP - 13

JO - Scientific Reports

JF - Scientific Reports

M1 - 5885

ER -

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

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