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Dexamethasone vs Burr Hole Craniostomy for cSDH
NCT02111785Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2014
- Primary completion
- Dec 2017
- Countries
- 1
- Sponsor
- University of Virginia
- Modality
- Orthosteric Ligands
- Drugs
- dexamethasone
- Conditions
- chronic subdural hematoma (CSDH)
01
Overview
Phase 3, randomised, open-label trial of dexamethasone in chronic subdural hematoma (CSDH) (4 arms), sponsored by University of Virginia. Primary endpoint: Number of Participants With a Modified Rankin Score of 0, 1 or 2 at 6 months. Started Mar 2014; status: terminated.
02
Design
4 arms- Study design
- RandomizedOpen-label
Burr Hole Randomized
Randomized to Burr Hole Craniostomy
Dexamethasone Randomized
Randomized to Dexamethasone
Burr Hole Observational
Selected Burr Hole Craniostomy
Dexamethasone Observational
Selected Dexamethasone
03
Who it enrols
Adult patients with symptomatic, unilateral chronic subdural hematoma (depth <20mm, shift <10mm) without skull fracture or need for urgent craniotomy.
04
Endpoints
Primary
Number of Participants With a Modified Rankin Score of 0, 1 or 2
Secondary
Rate of Treatment Failure
Participants With Modified Rankin Score 0, 1 or 2 at 6 Months
Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up
Participants With a Markwalder Grading Score of 0
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