Recruiting
Phase 2
Phase 3

Dexamethasone

Sponsor:

University of Calgary

Code:

NCT02938468

Conditions

Chronic Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dexamethasone

Any surgical intervention aim at treating chronic subdural hematoma

Study Details

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

Study ID

NCT02938468

Start date

Sep 17, 2016

Status verified date

Sep, 2016

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

326 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: Dexamethasone

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

Interventions

Dexamethasone

Any surgical intervention aim at treating chronic subdural hematoma

Primary outcome measure

  • Failure rates [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Clare Gallagher, MD.,PhD.

4039448447galclare@gmail.com

Michael Opoku-Darko, MD.,MSc.

mopokuda@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N1N4

Contacts

Clare Gallagher, MD.,PhD

4039448447galclare@gmail.com

Michael Opoku-Darko, MD.,MSc.

mopokuda@ucalgary.ca

Principal Investigator:

Clare Gallagher, MD.,PhD.

More Information

Sponsor

University of Calgary

Last update posted

Jul 1, 2020

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2020-07-01.