Clinical trial NCT02938468: Mgt of Chronic Subdural Hematoma Using Dexamethasone
Official title: Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Subdural Hematoma
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure rates
timeFrame: 3 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: 3 months
measure: Modified Ranking Scale
timeFrame: 1, 3 and 6 months after treatment
measure: Barthel index
timeFrame: 1, 3 and 6 months after treatment
measure: Glasgow Outcome Scale
timeFrame: 1, 3 and 6 months after treatment
measure: Glasgow Coma Scale
timeFrame: 1, 3 and 6 months after treatment
measure: Markwalder score
timeFrame: 1, 3 and 6 months after treatment
measure: Clinical improvement (Categorized as resolved, improved, unchanged or worse)
timeFrame: 1, 3 and 6 months after treatment
measure: Radiologic outcomes (Change in hematoma volume)
timeFrame: 1, 3 and 6 months after treatment
measure: Quality of Life measured using the EQ-5D-5L
timeFrame: 1, 3 and 6 months after treatment
measure: Mortality
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References: