Trial · NCT02111785
Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
NCT02111785, Phase 2, Phase 3, Terminated, University of Virginia; results first posted 2018-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma. Trials, record NCT02111785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02111785
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma
- NCT number
- NCT02111785
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Chronic Subdural Hematoma
- Interventions
- Dexamethasone, Burr Hole Craniostomy
- First posted
- 2014-04-11
- Last updated
- 2018-12-11
- Results first posted
- 2018-12-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | 6 months after diagnosis | 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. |
| Secondary | Rate of Treatment Failure | 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 |
| Secondary | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | 6 months after hospital discharge | 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. |
| Secondary | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | 6 months after hospital discharge | Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome. |
| Secondary | Participants With a Markwalder Grading Score of 0 | 6 months after hospital discharge | Markwalder Grading Score (MGS) The MGS is assessed as follows: Grade 0 - Patient neurologically normal Grade 1 - Patient alert and oriented; mild symptoms, such as headache; absent or mild symptoms or neurologic deficit, such as reflex asymmetry Grade 2 - Patient drowsy or disoriented with variable neurological deficit, such as hemiparesis Grade 3 - Patient stuporous but responding appropriately to noxious stimuli; several focal signs, such as hemiparesis Grade 4 - Patient comatose with absent motor response to painful stimuli; decerebrate or decorticate posturing. Higher scores mean a worse outcome. |
| Other | Rate of Radiographic Resolution of Chronic Subdural Hematoma | 6 months after diagnosis | The data were not collected. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Modified Rankin Score of 0, 1 or 2 | 6 months after diagnosis | Number of Participants with a modified Rankin Score of 0, 1 or 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Treatment Failure | 6 months after diagnosis | Reflects population analyzed for treatment failure. The one patient in the dexamethasone randomized group who died was not analyzed for this secondary outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | 6 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up | 6 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Participants With a Markwalder Grading Score of 0 | 6 months after hospital discharge | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Rate of Radiographic Resolution of Chronic Subdural Hematoma | 6 months after diagnosis |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Modified Rankin Score of 0, 1 or 2 | Burr Hole Craniostomy Randomized | 3 | Participants | ||
| Number of Participants With a Modified Rankin Score of 0, 1 or 2 | Dexamethasone Randomized | 4 | Participants | ||
| Number of Participants With a Modified Rankin Score of 0, 1 or 2 | Burr Hole Craniostomy Observational | 1 | Participants | ||
| Number of Participants With a Modified Rankin Score of 0, 1 or 2 | Dexamethasone Observational | 1 | Participants | ||
| Rate of Treatment Failure | Burr Hole Craniostomy Randomized | 0 | Participants | ||
| Rate of Treatment Failure | Dexamethasone Randomized | 0 | Participants | ||
| Rate of Treatment Failure | Burr Hole Craniostomy Observational | 0 | Participants | ||
| Rate of Treatment Failure | Dexamethasone Observational | 0 | Participants | ||
| Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | Burr Hole Craniostomy Randomized | 3 | Participants | ||
| Participants With Modified Rankin Score 0, 1 or 2 at 6 Months | Dexamethasone Randomized | 4 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Burr Hole Craniostomy Randomized | 3 | |
| Overall Study | STARTED | Dexamethasone Randomized | 5 | |
| Overall Study | STARTED | Burr Hole Craniostomy Observational | 1 | |
| Overall Study | STARTED | Dexamethasone Observational | 1 | |
| Overall Study | COMPLETED | Burr Hole Craniostomy Randomized | 3 | |
| Overall Study | COMPLETED | Dexamethasone Randomized | 4 | |
| Overall Study | COMPLETED | Burr Hole Craniostomy Observational | 1 | |
| Overall Study | COMPLETED | Dexamethasone Observational | 1 | |
| Overall Study | NOT COMPLETED | Burr Hole Craniostomy Randomized | 0 | |
| Overall Study | NOT COMPLETED | Dexamethasone Randomized | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Burr Hole Craniostomy Randomized | 0 | 3 |
| Total, all-cause mortality | Dexamethasone Randomized | 1 | 5 |
| Total, all-cause mortality | Burr Hole Craniostomy Observational | 0 | 1 |
| Total, all-cause mortality | Dexamethasone Observational | 0 | 1 |
| Total, other adverse events | Burr Hole Craniostomy Randomized | 0 | 3 |
| Total, other adverse events | Dexamethasone Randomized | 0 | 5 |
| Total, other adverse events | Burr Hole Craniostomy Observational | 0 | 1 |
| Total, other adverse events | Dexamethasone Observational | 0 | 1 |
| Total, serious adverse events | Burr Hole Craniostomy Randomized | 0 | 3 |
| Total, serious adverse events | Dexamethasone Randomized | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02111785
GET https://conductscience.org/api/trials/v1/NCT02111785/registered