Mgt of Chronic Subdural Hematoma Using Dexamethasone

NCT02938468 | Unknown Phase 2 DMC

• 1 other identifier: REB16-0219
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Recurrence rate

  3 months

• Modified Ranking Scale

  1, 3 and 6 months after treatment

• Barthel index

  1, 3 and 6 months after treatment

• Glasgow Outcome Scale

  1, 3 and 6 months after treatment

• Glasgow Coma Scale

  1, 3 and 6 months after treatment

Study Arms (2)

Surgery

ACTIVE COMPARATOR

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

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Also known as: Decadron

Dexamethasone

Any surgical intervention aim at treating chronic subdural hematoma PROCEDURE

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 yrs
• subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
• patient must be symptomatic

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Clare Gallagher, MD.,PhD.

CONTACT

4039448447; galclare@gmail.com

Michael Opoku-Darko, MD.,MSc.

CONTACT

mopokuda@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 19, 2016
• Study Start: September 17, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 1, 2020

Record last verified: 2016-09

Locations

CA (1)