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Mgt of Chronic Subdural Hematoma Using Dexamethasone

Phase 2
Conditions
Chronic Subdural Hematoma
Interventions
Procedure: Any surgical intervention aim at treating chronic subdural hematoma
Drug: Dexamethasone
Registration Number
NCT02938468
Lead Sponsor
University of Calgary
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
326
Inclusion Criteria
  • age ≥ 18 yrs
  • subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
  • patient must be symptomatic
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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SurgeryAny surgical intervention aim at treating chronic subdural hematomaPatients in this arm will receive any form if surgical intervention (i.e. bedside burrhole craniostomy, 2 burrhole washout, craniotomy, endoscopy etc.) for treatment of their chronic subdural hematoma
DexamethasoneDexamethasonePatients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma
Primary Outcome Measures
NameTimeMethod
Failure rates3 months

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

Secondary Outcome Measures
NameTimeMethod
Markwalder score1, 3 and 6 months after treatment

Functional outcome

Recurrence rate3 months

Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.

Barthel index1, 3 and 6 months after treatment

Functional outcome

Glasgow Outcome Scale1, 3 and 6 months after treatment

Functional outcome

Quality of Life measured using the EQ-5D-5L1, 3 and 6 months after treatment

Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.

Modified Ranking Scale1, 3 and 6 months after treatment

Functional outcome

Glasgow Coma Scale1, 3 and 6 months after treatment

Functional outcome

Clinical improvement (Categorized as resolved, improved, unchanged or worse)1, 3 and 6 months after treatment

Categorized as resolved, improved, unchanged or worse

Radiologic outcomes (Change in hematoma volume)1, 3 and 6 months after treatment

Measured as change in hematoma volume

Mortality1, 3 and 6 months

Trial Locations

Locations (1)

University of Calgary

🇨🇦

Calgary, Alberta, Canada

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