Mgt of Chronic Subdural Hematoma Using Dexamethasone

NCT ID: NCT02938468

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-17
• Study Completion Date: 2021-09-30

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.

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery

Patients 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

Group Type: ACTIVE_COMPARATOR

Any surgical intervention aim at treating chronic subdural hematoma

Intervention Type: PROCEDURE

Dexamethasone

Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Interventions

Dexamethasone

Intervention Type: DRUG

Any surgical intervention aim at treating chronic subdural hematoma

Intervention Type: PROCEDURE

Other Intervention Names

Decadron

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Clare Gallagher, MD.,PhD.

Role: CONTACT

galclare@gmail.com

4039448447

Michael Opoku-Darko, MD.,MSc.

Role: CONTACT

mopokuda@ucalgary.ca

Facility Contacts

Clare Gallagher, MD.,PhD

Role: primary

galclare@gmail.com

4039448447

Michael Opoku-Darko, MD.,MSc.

Role: backup

mopokuda@ucalgary.ca

Other Identifiers

REB16-0219

Identifier Type: -

Identifier Source: org_study_id