A study to compare surgery for chronic subdural haematoma with and without corticosteroids.

Prospective randomized clinical study of corticosteroids with surgery compared to surgery alone in patients with chronic subdural haematomas to reduce the reoccurence of chronic subdural haematomas (placebo-controlled double-blind study).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000175774

Acronym

NIL

Enrollment

100

Registered

2013-02-12

Start date

2013-11-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Corticosteroids (CS) are anti inflammatory agents and are frequently used in neurosurgical and neurological practice: they are a routine adjunct to surgery in patients with brain tumours worldwide. Several clinical studies have also demonstrated the utility and safety of CS as an alternative to surgery with CSDH: however, most studies have merely compared CS as ‘medical versus surgical management’. Only one study has directly compared the effects of CS as an adjunct to surgery: although a null effect was observed, the ‘surgery alone’ group consisted of only 13 subjects; and the study was not randomised. We propose to perform the first prospective, randomized, placebo-controlled double-blind clinical study of surgery for CSDH with and without corticosteroids as an adjunct. We aim to see whether surgery plus CS might reduce operative recurrences, in-patient stay and mortality.

Interventions

Surgery with corticosteroid (dexamethasone) oral capsule administered 4mg four times a day for 3 days and then reduced to 2mg three times a day for a maximum of 2 weeks. First dose is administered after onset of general anesthesia.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients aged 18yrs or more with demonstrated chronic subdural haematoma (CSDH) (either on CT or MRI or both) that is considered by the admitting neurosurgical team to be the cause of the patient's presenting symptoms and/or signs, and to be amenable to neurosurgical management will be considered suitable for study. All patients with diabetes mellitus will be discussed with an endocrinologist prior to commencing corticosteroid (CS).

Exclusion criteria

Children less than 18yrs will be excluded because the nature of CSDH in this group is entirely different to that observed in adults. Pregnant women will be excluded because CS can cause congenital malformations. Patients with a history of psychosis will be excluded because CS can provoke relapses.

Outcome results