Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

NCT02111785 | Terminated Phase 2 Results DMC

• 1 other identifier: 17294
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. The study hypothesis to be tested was: 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.

Conditions

Chronic Subdural Hematoma

Keywords

Dexamethasone; Burr hole craniostomy; Chronic subdural hematoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Modified Rankin Score of 0, 1 or 2

  The Modified Rankin Scale (mRS) The mRS is evaluated as follows: 0 - No symptoms 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Higher scores on the mRS scale mean a worse outcome.

  6 months after diagnosis

Secondary Outcomes (4)

• Rate of Treatment Failure

  6 months after diagnosis

• Participants With Modified Rankin Score 0, 1 or 2 at 6 Months

  6 months after hospital discharge

• Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up

  6 months after hospital discharge

• Participants With a Markwalder Grading Score of 0

  6 months after hospital discharge

Other Outcomes (1)

• Rate of Radiographic Resolution of Chronic Subdural Hematoma

  6 months after diagnosis

Study Arms (4)

Burr Hole Craniostomy randomized

ACTIVE COMPARATOR

Group receiving burr hole craniostomy and drainage of chronic subdural hematoma

Procedure: Burr Hole Craniostomy

Dexamethasone randomized

EXPERIMENTAL

Dexamethasone, tablet, initial dose 4mg q8h, total duration 15 days

Drug: Dexamethasone

Burr hole craniostomy observational

OTHER

Observational cohort of patients selecting burr hole craniostomy

Procedure: Burr Hole Craniostomy

Dexamethasone observational

OTHER

Observational cohort of patients treated with dexamethasone protocol

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Treatment with a short course of oral dexamethasone

Also known as: dex

Dexamethasone observational; Dexamethasone randomized

Burr Hole Craniostomy PROCEDURE

Treatment with surgical burr hole craniostomy and evacuation of SDH

Also known as: Burr hole drainage

Burr Hole Craniostomy randomized; Burr hole craniostomy observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Dexamethasone

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

Results Point of Contact

• Title: Dr. Daniel Raper
• Organization: Department of Neurosurgery, University of Virginia Health System

raper@virginia.edu

4349823244

Study Officials

• Jennifer De Jong

  University of Virginia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Locations

US (1)