Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial

study protocol for a randomised controlled trial

Angelos G. Kolias (Corresponding Author), Ellie Edlmann (Corresponding Author), Eric P. Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z. Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A. Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Carol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J. Marcus, Aswin Chari & 8 others Paul Brennan, Antonio Belli, Simon Bond, Carole Turner, Lynne Whitehead, Ian Wilkinson, Peter J. Hutchinson, British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators

Research output: Contribution to journalArticle

4 Citations (Scopus)
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Abstract

Background
Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.

Methods
Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.

Discussion
This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.

Trial registration
ISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.

Dex-CSDH trial protocol version 3, 27 Apr 2017.

This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.
Original languageEnglish
Article number670
Number of pages14
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - 4 Dec 2018

Fingerprint

Hematoma, Subdural, Chronic
Clinical Protocols
Dexamethasone
Randomized Controlled Trials
Steroids
Mortality
Length of Stay
Cerebrospinal Fluid Shunts
Economics
Morbidity
Recurrence
Subdural Hematoma
Checklist
Hematoma
Psychotic Disorders
Sample Size
Health Services
Drainage
Therapeutics
Placebos

Keywords

  • chronic subdural haematoma
  • dexamethasone
  • neurosurgery
  • neurology
  • randomised control trial

Cite this

Kolias, A. G., Edlmann, E., Thelin, E. P., Bulters, D., Holton, P., Suttner, N., ... British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators (2018). Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial. Trials, 19(1), [670]. https://doi.org/10.1186/s13063-018-3050-4

Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial : study protocol for a randomised controlled trial. / Kolias, Angelos G. (Corresponding Author); Edlmann, Ellie (Corresponding Author); Thelin, Eric P.; Bulters, Diederik; Holton, Patrick; Suttner, Nigel; Owusu-Agyemang, Kevin; Al-Tamimi, Yahia Z.; Gatt, Daniel; Thomson, Simon; Anderson, Ian A.; Richards, Oliver; Whitfield, Peter; Gherle, Monica; Caldwell, Karen; Davis-Wilkie, Carol; Tarantino, Silvia; Barton, Garry; Marcus, Hani J.; Chari, Aswin; Brennan, Paul; Belli, Antonio; Bond, Simon; Turner, Carole; Whitehead, Lynne; Wilkinson, Ian; Hutchinson, Peter J. (Corresponding Author); British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators.

In: Trials, Vol. 19, No. 1, 670, 04.12.2018.

Research output: Contribution to journalArticle

Kolias, AG, Edlmann, E, Thelin, EP, Bulters, D, Holton, P, Suttner, N, Owusu-Agyemang, K, Al-Tamimi, YZ, Gatt, D, Thomson, S, Anderson, IA, Richards, O, Whitfield, P, Gherle, M, Caldwell, K, Davis-Wilkie, C, Tarantino, S, Barton, G, Marcus, HJ, Chari, A, Brennan, P, Belli, A, Bond, S, Turner, C, Whitehead, L, Wilkinson, I, Hutchinson, PJ & British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators 2018, 'Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial', Trials, vol. 19, no. 1, 670. https://doi.org/10.1186/s13063-018-3050-4
Kolias, Angelos G. ; Edlmann, Ellie ; Thelin, Eric P. ; Bulters, Diederik ; Holton, Patrick ; Suttner, Nigel ; Owusu-Agyemang, Kevin ; Al-Tamimi, Yahia Z. ; Gatt, Daniel ; Thomson, Simon ; Anderson, Ian A. ; Richards, Oliver ; Whitfield, Peter ; Gherle, Monica ; Caldwell, Karen ; Davis-Wilkie, Carol ; Tarantino, Silvia ; Barton, Garry ; Marcus, Hani J. ; Chari, Aswin ; Brennan, Paul ; Belli, Antonio ; Bond, Simon ; Turner, Carole ; Whitehead, Lynne ; Wilkinson, Ian ; Hutchinson, Peter J. ; British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators. / Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial : study protocol for a randomised controlled trial. In: Trials. 2018 ; Vol. 19, No. 1.
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title = "Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial",
abstract = "BackgroundChronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20{\%} recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.MethodsDex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.DiscussionThis multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.Trial registrationISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.Dex-CSDH trial protocol version 3, 27 Apr 2017.This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.",
keywords = "chronic subdural haematoma, dexamethasone, neurosurgery, neurology, randomised control trial",
author = "Kolias, {Angelos G.} and Ellie Edlmann and Thelin, {Eric P.} 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 Peter Whitfield and Monica Gherle and Karen Caldwell and Carol Davis-Wilkie and Silvia Tarantino and Garry Barton and Marcus, {Hani J.} and Aswin Chari and Paul Brennan and Antonio Belli and Simon Bond and Carole Turner and Lynne Whitehead and Ian Wilkinson and Hutchinson, {Peter J.} and {British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators} 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 Emma Toman and Marian Vintu and Adam Wahba and Anthony Wiggins and Yakoub, {Kamal Makram} and Malik Zaben and Ardalan Zolnouria and Peter Bodkin and Emanuel Cirstea and Giles Critchley and Charlotte Eglinton and Kate Massey and Phyo Myint and Martin Smith and Jonathan Cook",
note = "Acknowledgements The following individuals should be indexed on PubMed as collaborators BNTRC collaborators: Khaled Badran, Ian Coulter, Mathew J Gallagher, Florence RA Hogg, Catherine Pringle, Adam Razak, Hamzah Soleiman, Rory Piper, Emma Toman, Marian Vintu, Adam Wahba, Anthony Wiggins, Kamal Makram Yakoub, Malik Zaben, Ardalan Zolnouria. Dex-CSDH trial collaborators: Peter Bodkin, Emanuel Cirstea, Giles Critchley, Charlotte Eglinton, Louise Finlay, Daniela Georgieva, Nihal Gurusinghe, Nikolaos Haliasos, Damian Holliman, Kismet Hossain-Ibrahim, Masood Hussain, Jothy Kandasamy, Mary Kambafwile, Phillip Kane, Dipankar Nandi, Ravindra Nannapaneni, Laura Ortiz-Ruiz de Gordoa, Marios C Papadopoulos, Dimitris Paraskevopoulos, Jash Patel, Manjunath Prasad, Nikolaos Tzerakis. Protocol contributors: Carol Brayne, Andrew Gardner, Andrew King, Kate Massey, Thais Minett, Patrick Mitchell, Phyo Myint, Elizabeth Warburton. TSC members: Professor Anthony Bell (Chair), Allison Hirst, Laurence Watkins, Peter McCabe. IDMEC members: Martin Smith (Chair), Joan Grieve, Jonathan Cook Funding This research was funded by the National Institute for Health Research Health Technology Assessment programme (NIHR HTA), project number 13/15/02. E Edlmann has received funding from the Royal College of Surgeons, Rosetrees Trust Research Fellowship. E Thelin is funded by post-doc stipends from the Swedish Society for Medical Research. PJH is supported by a Research Professorship from the National Institute for Health Research (NIHR) and by the NIHR Biomedical Research Centre, Cambridge.",
year = "2018",
month = "12",
day = "4",
doi = "10.1186/s13063-018-3050-4",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
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TY - JOUR

T1 - Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial

T2 - study protocol for a randomised controlled trial

AU - Kolias, Angelos G.

AU - Edlmann, Ellie

AU - Thelin, Eric P.

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 - Whitfield, Peter

AU - Gherle, Monica

AU - Caldwell, Karen

AU - Davis-Wilkie, Carol

AU - Tarantino, Silvia

AU - Barton, Garry

AU - Marcus, Hani J.

AU - Chari, Aswin

AU - Brennan, Paul

AU - Belli, Antonio

AU - Bond, Simon

AU - Turner, Carole

AU - Whitehead, Lynne

AU - Wilkinson, Ian

AU - Hutchinson, Peter J.

AU - British Neurosurgical Trainee Research Collaborative (BNTRC) and Dex-CSDH Trial Collaborators

A2 - Badran, Khaled

A2 - Coulter, Ian

A2 - Gallagher, Mathew J.

A2 - Hogg, Florence R. A.

A2 - Pringle, Catherine

A2 - Razak, Adam

A2 - Soleiman, Hamzah

A2 - Piper, Rory

A2 - Toman, Emma

A2 - Vintu, Marian

A2 - Wahba, Adam

A2 - Wiggins, Anthony

A2 - Yakoub, Kamal Makram

A2 - Zaben, Malik

A2 - Zolnouria, Ardalan

A2 - Bodkin, Peter

A2 - Cirstea, Emanuel

A2 - Critchley, Giles

A2 - Eglinton, Charlotte

A2 - Massey, Kate

A2 - Myint, Phyo

A2 - Smith, Martin

A2 - Cook, Jonathan

N1 - Acknowledgements The following individuals should be indexed on PubMed as collaborators BNTRC collaborators: Khaled Badran, Ian Coulter, Mathew J Gallagher, Florence RA Hogg, Catherine Pringle, Adam Razak, Hamzah Soleiman, Rory Piper, Emma Toman, Marian Vintu, Adam Wahba, Anthony Wiggins, Kamal Makram Yakoub, Malik Zaben, Ardalan Zolnouria. Dex-CSDH trial collaborators: Peter Bodkin, Emanuel Cirstea, Giles Critchley, Charlotte Eglinton, Louise Finlay, Daniela Georgieva, Nihal Gurusinghe, Nikolaos Haliasos, Damian Holliman, Kismet Hossain-Ibrahim, Masood Hussain, Jothy Kandasamy, Mary Kambafwile, Phillip Kane, Dipankar Nandi, Ravindra Nannapaneni, Laura Ortiz-Ruiz de Gordoa, Marios C Papadopoulos, Dimitris Paraskevopoulos, Jash Patel, Manjunath Prasad, Nikolaos Tzerakis. Protocol contributors: Carol Brayne, Andrew Gardner, Andrew King, Kate Massey, Thais Minett, Patrick Mitchell, Phyo Myint, Elizabeth Warburton. TSC members: Professor Anthony Bell (Chair), Allison Hirst, Laurence Watkins, Peter McCabe. IDMEC members: Martin Smith (Chair), Joan Grieve, Jonathan Cook Funding This research was funded by the National Institute for Health Research Health Technology Assessment programme (NIHR HTA), project number 13/15/02. E Edlmann has received funding from the Royal College of Surgeons, Rosetrees Trust Research Fellowship. E Thelin is funded by post-doc stipends from the Swedish Society for Medical Research. PJH is supported by a Research Professorship from the National Institute for Health Research (NIHR) and by the NIHR Biomedical Research Centre, Cambridge.

PY - 2018/12/4

Y1 - 2018/12/4

N2 - BackgroundChronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.MethodsDex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.DiscussionThis multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.Trial registrationISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.Dex-CSDH trial protocol version 3, 27 Apr 2017.This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.

AB - BackgroundChronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.MethodsDex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.DiscussionThis multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.Trial registrationISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.Dex-CSDH trial protocol version 3, 27 Apr 2017.This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.

KW - chronic subdural haematoma

KW - dexamethasone

KW - neurosurgery

KW - neurology

KW - randomised control trial

U2 - 10.1186/s13063-018-3050-4

DO - 10.1186/s13063-018-3050-4

M3 - Article

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 670

ER -