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Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma (DECS)

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ClinicalTrials.gov Identifier: NCT02111785
Recruitment Status : Recruiting
First Posted : April 11, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms including headache, confusion, limb weakness, and difficulty speaking.

There is currently no agreement among physicians as to the best way to treat this condition. One option is to do a surgery to drain the blood that has collected. Usually the surgery involves drilling small holes in the skull to relieve pressure and allow blood and fluids to be drained. Another option is to give medications such as steroids that might reduce the swelling. However, no drugs have been approved by the Food and Drug Administration (FDA) specifically to treat this condition. Some patients elect to have no treatment.

The purpose of this study is to investigate whether investigational treatment with a 2 week course of oral dexamethasone is as effective as surgery for cSDH. The study hypothesis to be tested is: For patients with unilateral, symptomatic chronic subdural hematoma, there is no difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2 at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with those treated with burr hole surgical drainage.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Dexamethasone Procedure: Burr Hole Craniostomy Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The DECS Trial: DExamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Burr Hole Craniostomy randomized
Group receiving burr hole craniostomy and drainage of chronic subdural hematoma
Procedure: Burr Hole Craniostomy
Other Name: Burr hole drainage
Experimental: Dexamethasone randomized
Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days
Drug: Dexamethasone
Burr hole craniostomy observational
Observational cohort of patients selecting burr hole craniostomy
Procedure: Burr Hole Craniostomy
Other Name: Burr hole drainage
Dexamethasone observational
Observational cohort of patients treated with dexamethasone protocol
Drug: Dexamethasone


Outcome Measures

Primary Outcome Measures :
  1. modified Rankin Score of 0, 1 or 2 [ Time Frame: 6 months after diagnosis ]

Secondary Outcome Measures :
  1. Rate of treatment failure [ Time Frame: 6 months after diagnosis ]
    This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group

  2. modified Rankin Score [ Time Frame: Hospital discharge (generally 3-7 days), 2 weeks, 4-6 weeks and 3 months after diagnosis ]
    modified Rankin Score at follow-up visits

  3. Glasgow Coma Score [ Time Frame: Hospital discharge (generally 3-7 days), 2 weeks, 4-6 weeks and 3 months after diagnosis ]
    Glasgow Comas Score at follow-up visits

  4. Markwalder Grading Score [ Time Frame: Hospital discharge (generally 3-7 days), 2 weeks, 4-6 weeks and 3 months after diagnosis ]
    Markwalder Grading Score at follow-up visits


Other Outcome Measures:
  1. Rate of radiographic resolution of chronic subdural hematoma [ Time Frame: 6 months after diagnosis ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject aged 18 years of age or older
  • Informed consent obtained from a patient or a legal representative before enrollment
  • Enrollment into the study within 12 hours of detection of chronic subdural hematoma on cranial imaging
  • Presence of symptoms referable to chronic subdural hematoma, including one or more of the following: Headache; altered mental status, limb weakness, dysphasia, or focal neurological deficit
  • Demonstration of unilateral chronic subdural hematoma on cranial imaging, including the following features: On computed tomography imaging, iso- or hypo-intensity extra-axial collection with or without presence of acute component; radiologic interpretation of magnetic resonance imaging consistent with subacute or chronic SDH; with or without evidence of acute hemorrhagic component
  • Maximum depth of subdural hematoma of less than 20mm, with less than 10mm of midline shift, as measured on axial CT or MR imaging
  • Absence of skull fracture over the subdural hematoma
  • Able to receive the drug treatment

Exclusion Criteria:

  • Presence of skull fracture over the subdural hematoma, or other specific etiology for cSDH not suitable for drainage by burr hole craniostomy, such as presence of a ventriculoperitoneal shunt
  • Extent of subdural hematoma > 20mm in maximal depth, or > 10mm of midline shift, as measured on axial CT or MR imaging
  • GCS <8 or cSDH of an extent or size for which craniotomy, rather than burr hole drainage alone, is judged necessary by the neurosurgery attending on call
  • Prior diagnosis of dementia
  • Presence of symptomatic peptic ulcer, psychosis, active or suspected TB, acute infection, or documented hypersensitivity or allergy to dexamethasone
  • Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding
Contacts and Locations

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): NCT02111785


Contacts
Contact: Daniel M Raper, MBBS 2023780329 raper@virginia.edu
Contact: Edward H Oldfield, MD 4349823591 eho4u@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Edward H Oldfield, MD    434-982-3591    eho4u@virdinia.edu   
Contact: Daniel M Raper, MBBS    2023780329    raper@virginia.edu   
Sub-Investigator: Daniel M Raper, MBBS         
Principal Investigator: Edward H Oldfield, MD         
Sub-Investigator: Robert M Starke, MD, MSc         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Edward H Oldfield, MD University of Virginia
More Information

Responsible Party: Edward Oldfield, MD, Crutchfield Chair in Neurosurgery, Professor of Neurosurgery and Internal Medicine, Head of Neuroendocrine Program, University of Virginia
ClinicalTrials.gov Identifier: NCT02111785     History of Changes
Other Study ID Numbers: 17294
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Edward Oldfield, MD, University of Virginia:
Dexamethasone
Burr hole craniostomy
Chronic subdural hematoma

Additional relevant MeSH terms:
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 acetate
Dexamethasone
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