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

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

doi:10.1186/s13063-019-3866-6

Cited by 9 publications

(10 citation statements)

References 17 publications

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“…Postoperative recurrence of subdural hematoma was a tertiary outcome that was defined as a symptomatic recurrence leading to reoperation of a previously evacuated ipsilateral chronic subdural hematoma. 19 Adverse events of special interest included hyperglycemia leading to treatment or discontinuation of the trial regimen, new-onset diabetes, hyperosmolar hyperglycemic state, new-onset psychosis, peptic ulceration or gastrointestinal bleeding, and other upper gastrointestinal side effects. 10…”

Section: Discussionmentioning

confidence: 99%

“…The independent data monitoring and ethics committee recommended that recruitment should continue to the original target sample size of 750 patients. The analysis was conducted according to a statistical analysis plan, 19 which was agreed on without reference to the unblinded data (see the protocol). No alpha-spending adjustment was required as a result of the 100-patient pilot trial, because this pilot phase was designed solely to determine the operational feasibility of continuing the trial.…”

Section: Discussionmentioning

confidence: 99%

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Trial of Dexamethasone for Chronic Subdural Hematoma

Hutchinson¹,

et al. 2020

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Trial of Dexamethasone for Chronic Subdural Hematoma

Hutchinson¹,

et al. 2020

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“…Finally, a small recent randomized control trial comparing corticosteroids to placebo among patients with cSDH found that steroids may decrease the risk of requiring surgical evacuation (38). Larger randomized clinical trials are underway to investigate this therapy (39)(40)(41).…”

Section: Demographic Characteristics and Treatmentmentioning

confidence: 99%

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

et al. 2020

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Chronic subdural hematoma (cSDH) is a common disease process associated with significant morbidity that occurs most often in elderly patients. Asymptomatic patients are typically treated conservatively, with surgical intervention reserved for patients with symptomatic and/or large hematomas that cause brain compression. However, conservatively managed cSDH cases frequently progress, and surgical evacuation of cSDH is associated with high rates of complication and recurrence. Recently, successful treatment of cSDH via middle meningeal artery (MMA) embolization has been reported in small case series and case reports. This article reviews the existing literature on MMA embolization for cSDH and discusses the need for randomized control trials and/or large prospective studies to establish the efficacy of MMA embolization for this disease.

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“…Clearly a rather robust inflammatory response of the brain to the initial SDH is elicited and persists ( 7 , 12 ). Recent trials have been directed at attenuating this response with dexamethasone or atorvastatin ( 19 , 20 , 37 ). There has also been much recent interest in middle meningeal artery (MMA) embolization for the treatment of cSDH.…”

Section: Discussionmentioning

confidence: 99%

“…Treatment options for cSDH include surgery (15)(16)(17), observation and medications such as dexamethasone (12,(18)(19)(20) and endovascular obliteration of the meningeal artery (21)(22)(23)(24)(25). There have been numerous studies examining the different procedures.…”

Section: Figure 2 |mentioning

confidence: 99%

The Mini-Craniotomy for cSDH Revisited: New Perspectives

Chen

Malkasian

et al. 2021

Front. Neurol.

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Background: Chronic subdural hematomas (cSDH) are increasingly prevalent worldwide with the increased aging population and anticoagulant use. Different surgical, medical, and endovascular treatments have had varying success rates. Primary neurosurgical interventions include burr hole drainage of the cSDH and mini-craniotomies/craniotomies with or without fenestration of the inner membrane. A key assessment of the success or failure of cSDH treatments has been symptomatic recurrence rates which have historically ranged from 5 to 30%. Pre-operative prediction of the inner subdural membrane by CT scan was used to guide our decision to perform mini-craniotomies. Release of the inner membrane facilitates the expansion of the brain and likely improves glymphatic flow.Methods: Consecutive mini-craniotomies (N = 34) for cSDH evacuation performed by a single neurosurgeon at a quaternary academic medical center/Level I trauma center from July 2018-September 2020 were retrospectively reviewed. Patient characteristics [age, gender, presenting GCS, GOS, initial CTs noting the inner subdural membrane, midline shift (MLS), cSDH width, inner membrane fenestration, cSDH recurrence, post-operative seizures, infections, length of stay] were extracted from the EMR.Results: Twenty nine patients had mini-craniotomies as primary treatment of the cSDH. Mean age = 68.9 ± 19.7 years (range 22–102), mean pre-operative GCS = 14.5 ± 1.1, mean MLS = 6.75 ± 4.2 mm, and mean maximum thickness of cSDH = 17.7 ± 6.0 mm. Twenty four were unilateral, five bilateral, 34 total craniotomies were performed. Thirty three had inner membrane signs on pre-operative head CTs and an inner subdural membrane was fenestrated in all cases except for the one craniotomy that didn't show these characteristic CT findings. Mean operating time = 79.5 ± 26.0 min. Radiographic and clinical improvement occurred in all patients. Mean improvement in MLS = 3.85 ± 2.69. There were no symptomatic recurrences, re-operations, surgical site infections, or deaths during the 6 months of follow-up. One patient was treated for post-operative seizures with AEDs for 6 months.Conclusion: Pre-operative CT scans demonstrating inner subdural membranes may guide one to target the treatment to allow release of this tension band. Mini-craniotomy with careful fenestration of the inner membrane is very effective for this. Brain re-expansion and re-establishment of normal brain interstitial flow may be important in long term outcomes with cSDH and may be related to the recent interests in brain glymphatics and dural lymphatics.

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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

Cited by 9 publications

References 17 publications

Trial of Dexamethasone for Chronic Subdural Hematoma

Trial of Dexamethasone for Chronic Subdural Hematoma

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

The Mini-Craniotomy for cSDH Revisited: New Perspectives

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