scholarly journals Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomised controlled trial

2020 ◽  
Author(s):  
Rong Cai Jiang ◽  
Dong Wang ◽  
Shi Guang Zhao ◽  
Ren Zhi Wang ◽  
De Zhi Kang ◽  
...  
Keyword(s):  
Subdural Haematoma ◽  
Low Dose ◽  
Controlled Trial ◽  
Combined Treatment ◽  
Chronic Subdural Hematoma ◽  
The Elderly ◽  
Chronic Subdural Haematoma ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Haematoma Volume

Abstract Background Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH. Methods The second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-center, randomized, placebo-controlled, double blind trial which aims to enroll 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition, and reduction in haematoma volumes at 14, 28 and 90 days. Discussion This multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH. Trial registration: ChiCTR, ChiCTR1900021659. Registered 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157

scholarly journals Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rong Cai Jiang ◽  
Dong Wang ◽  
Shi Guang Zhao ◽  
Ren Zhi Wang ◽  
De Zhi Kang ◽  
...  
Keyword(s):  
Subdural Haematoma ◽  
Low Dose ◽  
Controlled Trial ◽  
Combined Treatment ◽  
Chronic Subdural Hematoma ◽  
Chronic Subdural Haematoma ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Link Type ◽  
Haematoma Volume

Abstract Background Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH. Methods The second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-centre, randomized, placebo-controlled, double-blind trial which aims to enrol 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition and reduction in haematoma volumes at 14, 28 and 90 days. Discussion This multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH. Trial registration ChiCTR, ChiCTR1900021659. Registered on 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157.

scholarly journals The effect of low-dose aspirin on frailty phenotype and frailty index in community-dwelling older adults in the ASPirin in Reducing Events in the Elderly study

2021 ◽  
Author(s):  
Sara E Espinoza ◽  
Robyn L Woods ◽  
A R M Saifuddin Ekram ◽  
Michael E Ernst ◽  
Galina Polekhina ◽  
...  
Keyword(s):  
Older Adults ◽  
Low Dose ◽  
Controlled Trial ◽  
Frailty Index ◽  
The Elderly ◽  
Community Dwelling ◽  
Study Endpoint ◽  
Double Blind ◽  
Dose Aspirin ◽  
Low Dose Aspirin

Abstract BACKGROUND Frailty is associated with chronic inflammation, which may be modified by aspirin. The purpose of this study was to determine whether low dose aspirin reduces incident frailty in healthy older adult participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial. METHODS In the U.S and Australia, 19,114 community-dwelling individuals aged ≥70 years (U.S minorities ≥65 years) and free of overt cardiovascular disease, persistent physical disability, and dementia, were enrolled in ASPREE, a double-blind, placebo-controlled trial of 100mg daily aspirin versus placebo. Frailty, a pre-specified study endpoint, was defined according to a modified Fried frailty definition (Fried frailty) and the frailty index based on the deficit accumulation model (frailty index). Competing risk Cox proportional hazards models were used to compare time to incident frailty by aspirin versus placebo. Sensitivity analysis was conducted to include frailty data with and without imputation of missing data. RESULTS Over a median 4.7 years, 2252 participants developed incident Fried frailty, and 4451 had incident frailty according to the frailty index. Compared with placebo, aspirin treatment did not alter the risk of incident frailty (Fried frailty HR: 1.04, 95% CI 0.96-1.13; frailty index HR: 1.03, 95% CI 0.97-1.09). The proportion of individuals classified as frail, and the trajectory in continuous frailty scores over time, were not different between the aspirin and placebo treatment groups. The results were consistent across a series of subgroups. CONCLUSIONS Low dose aspirin use in healthy older adults when initiated in older ages does not reduce risk of incident frailty or the trajectory of frailty.

scholarly journals Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Annabel Allison ◽  
Ellie Edlmann ◽  
Angelos G. Kolias ◽  
Carol Davis-Wilkie ◽  
Harry Mee ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Subdural Haematoma ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Statistical Analysis Plan ◽  
Chronic Subdural Haematoma ◽  
Double Blind ◽  
Additional Material ◽  
Parallel Group ◽  
The Uk

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.

scholarly journals The Effect of Low-Dose Aspirin on Frailty in Older Adults in the Aspirin in Reducing Events in the Elderly Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 825-825
Author(s):  
Sara Espinoza ◽  
A R M Saifuddin Ekram ◽  
Robyn Woods ◽  
Michael Ernst ◽  
Galina Polekhina ◽  
...  
Keyword(s):  
Older Adults ◽  
Low Dose ◽  
Controlled Trial ◽  
Frailty Index ◽  
The Elderly ◽  
Community Dwelling ◽  
Deficit Accumulation ◽  
Double Blind ◽  
Dose Aspirin ◽  
Low Dose Aspirin

Abstract There are no widely accepted pharmacologic treatments for frailty prevention. Since frailty is associated with inflammation, aspirin has the potential to reduce frailty. We investigated whether low-dose aspirin reduces incident frailty in participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial. In the U.S and Australia, 19,114 healthy community-dwelling individuals aged ≥70 years (U.S. minorities ≥65 years) were enrolled in ASPREE, a double-blind, placebo-controlled trial of 100mg daily low-dose aspirin vs. placebo. Frailty was defined according to a modified Fried frailty definition, and a frailty index which used a deficit accumulation model. Competing risk Cox proportional hazards models were used to compare time to incident frailty for aspirin vs. placebo. At baseline, 2.2% and 8.1% met criteria for frailty by Fried and frailty index criteria, respectively. Over a median of 4.7 years of follow-up, 2252 participants developed incident frailty according to Fried classification, and 4376 according to the frailty deficit accumulation index. There was no difference in the risk of incident frailty between individuals randomized to aspirin versus placebo according to either criteria (Fried frailty HR: 1.03, 95% CI 0.97-1.09, p=0.41; frailty index HR: 1.03, 95% CI 0.97-1.10, p=0.29). Change in frailty over time was not different between the aspirin and placebo treatment arms. The results were consistent across a series of sub-groups, including baseline frailty status. Based on these results, aspirin use in healthy older adults does not reduce incident frailty.

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