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Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma

NCT02111785 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-11

Study results available
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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

Interventions

DRUG

Dexamethasone

Treatment with a short course of oral dexamethasone

PROCEDURE

Burr Hole Craniostomy

Treatment with surgical burr hole craniostomy and evacuation of SDH

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jennifer De Jong · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02111785 on ClinicalTrials.gov