Clinical Trial: Mgt of Chronic Subdural Hematoma Using Dexamethasone

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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. 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 trial
Sponsor: University of Calgary

Current Primary Outcome: Failure rates [ Time Frame: 3 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence rate [ Time Frame: 3 months ]
    Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.
  • Modified Ranking Scale [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome
  • Barthel index [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome
  • Glasgow Outcome Scale [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome
  • Glasgow Coma Scale [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome
  • Markwalder score [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome
  • Clinical improvement (Categorized as resolved, improved, unchanged or worse) [ Time Frame: 1, 3 and 6 months after treatment ]
    Categorized as resolved, improved, unchanged or worse
  • Radiologic outcomes (Change in hematoma volume) [ Time Frame: 1, 3 and 6 months after treatment ]
    Measured as change in hematoma volume
  • Quality of Life measured using the EQ-5D-5L [ Time Frame: 1, 3 and 6 months after treatment ]
    Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.
  • Mortality [ Time Frame: 1, 3 and 6 months ]


Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: September 21, 2016
Date Started: September 2016
Date Completion: September 2018
Last Updated: October 18, 2016
Last Verified: October 2016