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Mgt of Chronic Subdural Hematoma Using Dexamethasone

Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02938468
Enrollment
326
Registered
2016-10-19
Start date
2016-09-17
Completion date
2021-09-30
Last updated
2020-07-01

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

Conditions

Chronic Subdural Hematoma

Brief summary

Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. Management of cSDH is widely varied. A wait-and-see or wait-and-rescan approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors. Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.

Detailed description

Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. The one-year incidence rate is 1 to 8.2 per 100 000 in those 65 years or older. Advanced age is one of several risk factors and the incidence is expected to increase due to improved life expectancy. Other risk factors include brain atrophy, chronic alcoholism, intracranial hypotension, male gender and coagulopathy (including antiplatelet and antithrombotic therapy). Management of cSDH is widely varied. A wait-and-see or wait-and-rescan approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors. Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.

Interventions

DRUGDexamethasone
PROCEDUREAny surgical intervention aim at treating chronic subdural hematoma

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age ≥ 18 yrs * subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment * patient must be symptomatic

Exclusion criteria

* Glasgow Coma Scale (GCS) ≤ 12 * patients needing craniotomy at the discretion of the on call neurosurgeon * hemiparesis with less than antigravity (≤ 3/5 medical research council scale) strength in any testable myotomes °≥ 2 seizures at presentation or history of epilepsy * subdural hematoma with an underlying lesion or condition such as tumor, arachnoid cyst, presence of a ventriculoperitoneal shunt or vascular malformation * contraindication to dexamethasone including allergy or hypersensitivity to dexamethasone, immunocompromised/immunosuppressed patients, uncontrolled diabetes, untreated known peptic ulcer disease * pregnant/breastfeeding mothers * acute infection including latent/active tuberculosis (TB) * history of psychosis * anticoagulated for mechanical heart valve or arterial stent (i.e. coronary, carotid, or peripheral) placement * small volume, non-operable subdural collection

Design outcomes

Primary

MeasureTime frameDescription
Failure rates3 monthsFailure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.

Secondary

MeasureTime frameDescription
Radiologic outcomes (Change in hematoma volume)1, 3 and 6 months after treatmentMeasured as change in hematoma volume
Clinical improvement (Categorized as resolved, improved, unchanged or worse)1, 3 and 6 months after treatmentCategorized as resolved, improved, unchanged or worse
Recurrence rate3 monthsRecurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.
Modified Ranking Scale1, 3 and 6 months after treatmentFunctional outcome
Markwalder score1, 3 and 6 months after treatmentFunctional outcome
Glasgow Outcome Scale1, 3 and 6 months after treatmentFunctional outcome
Glasgow Coma Scale1, 3 and 6 months after treatmentFunctional outcome
Quality of Life measured using the EQ-5D-5L1, 3 and 6 months after treatmentQuality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.
Mortality1, 3 and 6 months
Barthel index1, 3 and 6 months after treatmentFunctional outcome

Countries

Canada

Contacts

Primary ContactClare Gallagher, MD.,PhD.
galclare@gmail.com4039448447
Backup ContactMichael Opoku-Darko, MD.,MSc.
mopokuda@ucalgary.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026