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Article ; Online: Continuous glucose monitoring in extremely preterm infants in intensive care

Kathryn Beardsall / Lynn Thomson / Catherine Guy / Simon Bond / Annabel Allison / Beatrice Pantaleo / Stavros Petrou / Sungwook Kim / David Dunger / Roman Hovorka

Efficacy and Mechanism Evaluation, Vol 8, Iss

the REACT RCT and pilot study of ‘closed-loop’ technology

2021 Volume 16

Abstract: Background: Hyperglycaemia and hypoglycaemia are common in preterm infants and are associated with increased mortality and morbidity. Continuous glucose monitoring is widely used to target glucose control in adults and children, but not in neonates. ... ...

Abstract	Background: Hyperglycaemia and hypoglycaemia are common in preterm infants and are associated with increased mortality and morbidity. Continuous glucose monitoring is widely used to target glucose control in adults and children, but not in neonates. Objective: To evaluate the role of continuous glucose monitoring in the preterm infant. Design: The REAl-time Continuous glucose moniToring in neonatal intensive care project combined (1) a feasibility study, (2) a multicentre randomised controlled trial and (3) a pilot of ‘closed-loop’ continuous glucose monitoring. The feasibility study comprised a single-centre study (n = 20). Eligibility criteria included a birthweight ≤ 1200 g and aged ≤ 48 hours. Continuous glucose monitoring was initiated to support glucose control. The efficacy and safety outcomes guided the design of the randomised controlled trial. The randomised controlled trial comprised a European multicentre trial (n = 182). Eligibility criteria included birthweight ≤ 1200 g and aged ≤ 24 hours. Exclusion criteria included any lethal congenital abnormality. Continuous glucose monitoring was initiated to support glucose control within 24 hours of birth. In the intervention group, the continuous glucose monitoring sensor provided real-time data on glucose levels, which guided clinical management. In control infants, the continuous glucose monitoring data were masked, and glucose level was managed in accordance with standard clinical practice and based on the blood glucose levels. The primary outcome measure was the percentage of time during which the sensor glucose level was within the target range of 2.6–10 mmol/l. Secondary outcome measures included mean sensor glucose level, the percentage of time during which the sensor glucose level was within the target range of 4–8 mmol/l, the percentage of time during which the sensor glucose level was in the hyperglycaemic range (i.e. > 15 mmol/l) and sensor glucose level variability. Safety outcomes included hypoglycaemia exposure. Acceptability assessment ...
Keywords	glucose ; hyperglycaemia ; hypoglycaemia ; intensive care ; neonatal ; preterm ; monitoring ; Medicine ; R
Subject code	670
Language	English
Publishing date	2021-10-01T00:00:00Z
Publisher	NIHR Journals Library
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Social and medical needs of rare metabolic patients

Sylvia Sestini / Laura Paneghetti / Christina Lampe / Gianni Betti / Simon Bond / Cinzia Maria Bellettato / Scarpa Maurizio

Orphanet Journal of Rare Diseases, Vol 16, Iss 1, Pp 1-

results from a MetabERN survey

2021 Volume 13

Abstract: Abstract Background Many surveys have been performed over the years to assess the medical and social requirements of patients with a rare disease, but no studies have focused specifically on patients in Europe or with an inherited metabolic disease (IMD). ...

Abstract	Abstract Background Many surveys have been performed over the years to assess the medical and social requirements of patients with a rare disease, but no studies have focused specifically on patients in Europe or with an inherited metabolic disease (IMD). To obtain a comprehensive overview of the social and psychological status and needs of IMD patients, especially in Europe, the European Reference Network for Hereditary Metabolic Disorders (MetabERN) has performed a dedicated survey among its metabolic patients. Results A total of 924 patients and caregivers responded to the questionnaire. Most participants were from 25 European countries, with Spain, Italy, and Germany being the most represented; only eight participants were extra-European. The survey showed that most social assistance services, from free educational/development services for those with intellectual disability to transition from childhood to adult care and job placement support, are available for a limited number of patients or are unknown to the majority of patients or their parents/caregivers. Similarly, psychological assistance for the patient or the parent/caregiver is available for a small fraction of respondents, despite the fact that the majority considers this type of support necessary for both the patient and the caregiver. In addition, for most IMD patients local specialised or emergency medical assistance is lacking, although national clinical pathways are defined, and medical professionals of reference are readily available when needed. Lastly, while most national health services in Europe cover all or part of the expenses for medications, medical devices, food supplements, dietary integrators, physiotherapy, and speech therapy, significant gaps in the economic support for healthcare and other expenses still exist. Conclusions Overall, our survey reveals a widespread lack of social, psychological, and economic support for IMD patients in Europe. More needs to be done to provide daily assistance to IMD patients in order to alleviate ...
Keywords	Rare diseases ; Inherited metabolic diseases ; IMDs ; Social services ; Psychological support ; Medicine ; R
Subject code	027
Language	English
Publishing date	2021-08-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Repurposed Drugs (TACTIC-R)

Spoorthy Kulkarni / Marie Fisk / Michalis Kostapanos / Edward Banham-Hall / Simon Bond / Elena Hernan-Sancho / Sam Norton / Joseph Cheriyan / Andrew Cope / James Galloway / Frances Hall / David Jayne / Ian B. Wilkinson

Trials, Vol 21, Iss 1, Pp 1-

A structured summary of a study protocol for a randomised controlled trial

2020 Volume 3

Abstract: Abstract Objectives To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC). Trial design Randomised, parallel 3-arm (1:1:1 ratio), open-label, ...

Abstract	Abstract Objectives To determine if a specific immunomodulatory intervention reduces progression of COVID-19-related disease to organ failure or death, compared to standard of care (SoC). Trial design Randomised, parallel 3-arm (1:1:1 ratio), open-label, Phase IV platform trial of immunomodulatory therapies in patients with late stage 1 or stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and/or radiological assessment. Participants Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a Risk count (as defined below) >3 OR ≥3 if risk count includes “Radiographic severity score >3”. A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x109/L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory therapies in the opinion of the investigator and be able to be maintained on venous thromboembolism prophylaxis during the inpatient dosing period, according to local guidelines. The complete inclusion and exclusion criteria as detailed in the additional file 1 should be fulfilled. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres including initially at Cambridge University Hospitals NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, Guy’s and St Thomas’ NHS Foundation Trust, University Hospital of Wales, Gloucestershire Royal Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust. Intervention and comparator Each active comparator arm will be compared against standard of care (SoC). The immunomodulatory drugs were selected from a panel of licenced candidates by a drug evaluation ...
Keywords	COVID-19 ; Randomised controlled trial ; Protocol ; Baricitinib ; Ravulizumab ; Open-label ; Medicine (General) ; R5-920 ; covid19
Subject code	610
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E)

Ing Ni Lu / Spoorthy Kulkarni / Marie Fisk / Michalis Kostapanos / Edward Banham-Hall / Sonakshi Kadyan / Simon Bond / Sam Norton / Andrew Cope / James Galloway / Frances Hall / David Jayne / Ian B. Wilkinson / Joseph Cheriyan

Trials, Vol 21, Iss 1, Pp 1-

A structured summary of a study protocol for a randomized controlled trial

2020 Volume 3

Abstract: Abstract Objectives To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ... ...

Abstract	Abstract Objectives To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min). Trial design Randomised, parallel arm, open-label, adaptive platform Phase 2/3 trial of potential disease modifying therapies in patients with late stage 1/stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical, laboratory and radiological assessment. Participants Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a risk count (as defined below) >3 OR ≥3 if risk count includes “Radiographic severity score >3”. A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x109/L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator and are able to swallow capsules or tablets. The complete inclusion and exclusion criteria as detailed in the Additional file 1 should be fulfilled. Drug specific inclusion and exclusion criteria will also be applied to the active arms. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres in the UK including initially at Cambridge University Hospitals NHS Foundation Trust and St George’s University NHS Foundation Trust. Other centres will be approached internationally in view of the evolving pandemic. Intervention and ...
Keywords	COVID-19 ; Randomised controlled trial ; Protocol ; Open-label ; Adaptive trial ; EDP1815 ; Medicine (General) ; R5-920 ; covid19
Subject code	610
Language	English
Publishing date	2020-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Targeting patient recovery priorities in degenerative cervical myelopathy

Ian B Wilkinson / Simon Bond / Lynne Whitehead / Benjamin Davies / Sarah Lamb / Martin Wilby / Oliver D Mowforth / Iwan Sadler / Michael G Fehlings / Jon Bishop / Siddharthan Chandran / Marianna Nodale / Michelle Starkey / Mark R N Kotter / Peter John Hutchinson / David Choi / Marios C Papadopoulos / Paula Kareclas / Adrian Carpenter /

Rikin A Trivedi / Sukhvinder Kalsi-Ryan / Stefan Yordanov / Daniel Alvarez-Berdugo / Mark Bacon / Lara Smith

BMJ Open, Vol 13, Iss

design and rationale for the RECEDE-Myelopathy trial—study protocol

2023 Volume 3

Abstract: Introduction Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. ... ...

Abstract	Introduction Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. RECEDE-Myelopathy aims to test the disease-modulating activity of the phosphodiesterase 3/phosphodiesterase 4 inhibitor Ibudilast as an adjuvant to surgical decompression in DCM.Methods and analysis RECEDE-Myelopathy is a multicentre, double-blind, randomised, placebo-controlled trial. Participants will be randomised to receive either 60–100 mg Ibudilast or placebo starting within 10 weeks prior to surgery and continuing for 24 weeks after surgery for a maximum of 34 weeks. Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8–14 inclusive and are scheduled for their first decompressive surgery are eligible for inclusion. The coprimary endpoints are pain measured on a visual analogue scale and physical function measured by the mJOA score at 6 months after surgery. Clinical assessments will be undertaken preoperatively, postoperatively and 3, 6 and 12 months after surgery. We hypothesise that adjuvant therapy with Ibudilast leads to a meaningful and additional improvement in either pain or function, as compared with standard routine care.Study design Clinical trial protocol V.2.2 October 2020.Ethics and dissemination Ethical approval has been obtained from HRA—Wales.The results will be presented at an international and national scientific conferences and in a peer-reviewed journals.Trial registration number ISRCTN Number: ISRCTN16682024.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Statistical analysis plan for the Dex-CSDH trial

Annabel Allison / Ellie Edlmann / Angelos G. Kolias / Carol Davis-Wilkie / Harry Mee / Eric P. Thelin / Carole Turner / Peter J. Hutchinson / Simon Bond

Trials, Vol 20, Iss 1, Pp 1-

a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma

2019 Volume 5

Abstract: Abstract Background The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched ...

Abstract	Abstract Background The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. Methods and design Dex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0–3) versus unfavourable (a score of 4–6). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.
Keywords	Dexamethasone ; Chronic subdural haematoma ; Randomised trial ; Steroid ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2019-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Study of induction of Tolerance to Oral Peanut

Katherine Anagnostou / Sabita Islam / Yvonne King / Loraine Foley / Laura Pasea / Chris Palmer / Simon Bond / Pamela Ewan / Andrew Clark

Efficacy and Mechanism Evaluation, Vol 1, Iss

a randomised controlled trial of desensitisation using peanut oral immunotherapy in children (STOP II)

2014 Volume 4

Abstract: Background: Peanut allergy is a common disease that causes severe and fatal food allergic reactions. Currently, the best treatment is avoidance as repeated reactions can occur. Quality of life (QoL) is reduced by fear of severe reactions and social ... ...

Abstract	Background: Peanut allergy is a common disease that causes severe and fatal food allergic reactions. Currently, the best treatment is avoidance as repeated reactions can occur. Quality of life (QoL) is reduced by fear of severe reactions and social limitations. Oral immunotherapy (OIT) is a novel treatment that may be an effective treatment for peanut allergy. Objectives: To determine the efficacy of peanut OIT in children. Design: A phase 2 randomised, controlled, crossover trial (open label). Setting: Single UK centre study. Participants: Children aged 7–15 years with peanut allergy diagnosed by double-blind, placebo-controlled food challenge (DBPCFC). No children were excluded because of anaphylaxis or asthma. Interventions: Daily immunotherapy (2 mg, 5 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg of peanut protein) was administered as peanut flour (containing 50% peanut protein). Doses were increased at 2-weekly intervals to a maintenance dose of 800 mg of protein. The control group underwent peanut avoidance for 6 months during phase 1. Main outcome measure: A peanut DBPCFC up to 1400 mg of peanut protein was performed in both groups at 6 months. The highest amount of peanut tolerated was the main outcome measure. Randomisation: Randomised by online audited system to active or control group (1 : 1). Blinding: The intervention arm allocation was not blinded. Methods: We assigned 99 participants aged 7–16 years with peanut allergy of all severities to active OIT or control (peanut avoidance/current standard of care). The primary outcome was desensitisation, defined as negative peanut challenge (1400 mg of protein DBPCFC) at 6 months (phase 1). Control participants underwent OIT during phase 2, followed by DBPCFC. Immunological parameters and disease-specific QoL scores were measured. Results: The primary outcome, desensitisation, was observed in 62% (24/39) of the active group and none (0/46) of the control group after phase 1 [95% confidence interval (CI) 45% to 78% vs. 0% to 9%; p < ...
Keywords	tolerance ; peanut ; oral immunotherapy ; randomised controlled trial ; desensitisation ; children ; Medicine ; R
Subject code	610
Language	English
Publishing date	2014-12-01T00:00:00Z
Publisher	NIHR Journals Library
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: P29 MECHANISMS OF VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITION INDUCED HYPERTENSION

Kaisa Maki-Petaja / Adam McGeoch / Lucy Yang / Annette Hubsch / Carmel McEniery / Fraz Mir / Parag Gajendragadkar / Nicola Ramenatte / Gayathri Anandappa / Christoph Brune / Yoeri Boink / Carola Bibiane-Schonlieb / Paul Meyer / Simon Bond / Ian Wilkinson / Duncan Jodrell / Joseph Cheriyan

Artery Research, Vol

2018 Volume 24

Abstract: Introduction: Drugs targeting Vascular Endothelial Growth Factor (VEGF) signaling pathway are approved therapies for cancer. Unfortunately, VEGF inhibitors lead to hypertension in 30-80% patients. Reduced nitric oxide synthase activity and increased ... ...

Abstract	Introduction: Drugs targeting Vascular Endothelial Growth Factor (VEGF) signaling pathway are approved therapies for cancer. Unfortunately, VEGF inhibitors lead to hypertension in 30-80% patients. Reduced nitric oxide synthase activity and increased vascular resistance have been proposed as potential mechanisms. We aimed to assess these mechanisms in oncology patients receiving VEGF inhibitor, pazopanib (NCT01392352). Methods: 27 normotensive patients received pazopanib 800mg od. Endothelial function was assessed using forearm plethysmography with intra-arterial infusion of Acetylcholine (ACh), Sodium Nitroprusside (SNP) and L-N-monomethyl-arginine (L-NMMA). Also, Blood Pressure (BP), Pulse Wave Velocity (PWV), Cardiac Output (CO), and Peripheral Vascular Resistance (PVR) and capillary density in the eye were assessed. All measurements were taken at baseline, 2 and 12 weeks after initiation of the treatment. Results: Following 12 weeks of treatment, systolic BP rose by 12 (95% CI:4–19) mmHg; P = 0.003, diastolic by 10 (95% CI:5–15) mmHg; P < 0.001, PWV by 1.3 (95% CI:0.3–2.2) m/s; P = 0.01, PVR by 11.1 (95% CI:7.7–14.6) mmHg*L/min; P < 0.001. Capillary density in the sclera reduced by 12 ± 18%; P = 0.02. Forearm blood flow response to ACh improved (P < 0.001), whereas SNP and L-NMMA responses were unchanged. A post-hoc colorimetric assay revealed in whole blood from healthy volunteers that pazopanib inhibited acetylcholinesterase activity by 35%. Conclusion: Unexpectedly, pazopanib led to an increase in ACh response, but this is most likely due to the inhibition of acetylcholinesterase activity by pazopanib. Interestingly, we found that PVR was increased and capillary density reduced by the treatment, suggesting that capillary rarefaction could be one of the mechanisms behind VEGF inhibition induced hypertension.
Keywords	Specialties of internal medicine ; RC581-951 ; Diseases of the circulatory (Cardiovascular) system ; RC666-701
Subject code	610
Language	English
Publishing date	2018-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Correction to

Angelos G. Kolias / Ellie Edlmann / 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 / 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

Trials, Vol 20, Iss 1, Pp 1-

Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial

2019 Volume 1

Abstract: After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled. ...

Abstract	After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.
Keywords	Medicine (General) ; R5-920
Language	English
Publishing date	2019-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
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Article ; Online: Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial

Trials, Vol 19, Iss 1, Pp 1-

study protocol for a randomised controlled trial

2018 Volume 14

Abstract: 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. ...

Abstract	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.
Keywords	Chronic subdural haematoma ; Dexamethasone ; Neurosurgery ; Neurology ; Randomised control trial ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2018-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
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