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NCT02111785 · ClinicalTrials.gov registry record · Phase 2
Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
A Phase 2 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02111785: Clinical Trial Phase 2 study, sponsored by University of Virginia.
NCT02111785 is a Phase 2 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111785, a Phase 2 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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 unassis
Interventions
- DRUG Dexamethasone
- PROCEDURE Burr Hole Craniostomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
Why NCT02111785 stopped before completion
NCT02111785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT02111785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02111785 about?
NCT02111785 is a clinical study titled "Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma". 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 ...
What is the current status of trial NCT02111785?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-03. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02111785?
The interventions under investigation include: Dexamethasone (DRUG), Burr Hole Craniostomy (PROCEDURE).
Who is sponsoring clinical trial NCT02111785?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02111785's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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