Mgt of Chronic Subdural Hematoma Using Dexamethasone

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Drug: Dexamethasone; Procedure: Any surgical intervention aim at treating chronic subdural hematoma

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.

• Study Type: Interventional
• Enrollment (Anticipated): 326
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Clare Gallagher, MD.,PhD.; Phone Number: 4039448447; Email: galclare@gmail.com
• Study Contact Backup: Name: Michael Opoku-Darko, MD.,MSc.; Email: mopokuda@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N1N4
      • Recruiting
      • University of Calgary
      • Contact: Michael Opoku-Darko, MD.,MSc.; Email: mopokuda@ucalgary.ca
      • Contact: Clare Gallagher, MD.,PhD; Phone Number: 4039448447; Email: galclare@gmail.com
      • Principal Investigator: Clare Gallagher, MD.,PhD.
      • Sub-Investigator: Steve Casha, MD.,PhD.
      • Sub-Investigator: Michael Opoku-Darko, MD.,MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Any surgical intervention aim at treating chronic subdural hematoma
Experimental: Dexamethasone; Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma	Drug: Dexamethasone; Other Names: Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Modified Ranking Scale	Functional outcome	1, 3 and 6 months after treatment
Barthel index	Functional outcome	1, 3 and 6 months after treatment
Glasgow Outcome Scale	Functional outcome	1, 3 and 6 months after treatment
Glasgow Coma Scale	Functional outcome	1, 3 and 6 months after treatment
Markwalder score	Functional outcome	1, 3 and 6 months after treatment
Clinical improvement (Categorized as resolved, improved, unchanged or worse)	Categorized as resolved, improved, unchanged or worse	1, 3 and 6 months after treatment
Radiologic outcomes (Change in hematoma volume)	Measured as change in hematoma volume	1, 3 and 6 months after treatment
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
Mortality		1, 3 and 6 months

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: REB16-0219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided