Mgt of Chronic Subdural Hematoma Using Dexamethasone

Chronic Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02938468
• Other study ID #: REB16-0219
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 17, 2016
• Est. completion date: September 2021

Study information

• Verified date: September 2016
• Source: University of Calgary
• Contact: Clare Gallagher, MD.,PhD.
• Phone: 4039448447
• Email: galclare[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Dexamethasone

Procedure:
• Any surgical intervention aim at treating chronic subdural hematoma

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rates	Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.	3 months
Secondary	Recurrence rate	Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.	3 months
Secondary	Modified Ranking Scale	Functional outcome	1, 3 and 6 months after treatment
Secondary	Barthel index	Functional outcome	1, 3 and 6 months after treatment
Secondary	Glasgow Outcome Scale	Functional outcome	1, 3 and 6 months after treatment
Secondary	Glasgow Coma Scale	Functional outcome	1, 3 and 6 months after treatment
Secondary	Markwalder score	Functional outcome	1, 3 and 6 months after treatment
Secondary	Clinical improvement (Categorized as resolved, improved, unchanged or worse)	Categorized as resolved, improved, unchanged or worse	1, 3 and 6 months after treatment
Secondary	Radiologic outcomes (Change in hematoma volume)	Measured as change in hematoma volume	1, 3 and 6 months after treatment
Secondary	Quality of Life measured using the EQ-5D-5L	Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.	1, 3 and 6 months after treatment
Secondary	Mortality		1, 3 and 6 months