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Mgt of Chronic Subdural Hematoma Using Dexamethasone

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ClinicalTrials.gov Identifier: NCT02938468
Recruitment Status : Unknown
Verified October 2016 by University of Calgary.
Recruitment status was:  Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Calgary

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.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Dexamethasone Procedure: Any surgical intervention aim at treating chronic subdural hematoma Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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 Name: Decadron




Primary Outcome Measures :
  1. Failure rates [ Time Frame: 3 months ]
    Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.


Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: 3 months ]
    Recurrence is defined as symptomatic and radiologic re-accumulation of subdural hematoma on the ipsilateral side requiring a reoperation within 3months after treatment.

  2. Modified Ranking Scale [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome

  3. Barthel index [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome

  4. Glasgow Outcome Scale [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome

  5. Glasgow Coma Scale [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome

  6. Markwalder score [ Time Frame: 1, 3 and 6 months after treatment ]
    Functional outcome

  7. Clinical improvement (Categorized as resolved, improved, unchanged or worse) [ Time Frame: 1, 3 and 6 months after treatment ]
    Categorized as resolved, improved, unchanged or worse

  8. Radiologic outcomes (Change in hematoma volume) [ Time Frame: 1, 3 and 6 months after treatment ]
    Measured as change in hematoma volume

  9. Quality of Life measured using the EQ-5D-5L [ Time Frame: 1, 3 and 6 months after treatment ]
    Quality of life will be measured using the EuroQol health survey (EQ-5D-5L) questionnaire.

  10. Mortality [ Time Frame: 1, 3 and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938468


Contacts
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Contact: Clare Gallagher, MD.,PhD. 4039448447 galclare@gmail.com
Contact: Michael Opoku-Darko, MD.,MSc. mopokuda@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N1N4
Contact: Clare Gallagher, MD.,PhD    4039448447    galclare@gmail.com   
Contact: Michael Opoku-Darko, MD.,MSc.       mopokuda@ucalgary.ca   
Principal Investigator: Clare Gallagher, MD.,PhD.         
Sub-Investigator: Steve Casha, MD.,PhD.         
Sub-Investigator: Michael Opoku-Darko, MD.,MSc.         
Sponsors and Collaborators
University of Calgary

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT02938468     History of Changes
Other Study ID Numbers: REB16-0219
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Hemorrhage
Pathologic Processes
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
Wounds and Injuries
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents