Paper snapshot
Rapid study overview
DOI
10.1056/NEJMoa2214172
PMID
N/A
PICO
Population
Adult patients (age >16) with traumatic acute subdural hematoma requiring surgical evacuation with a bone flap ≥11 cm
Intervention
Decompressive craniectomy (bone flap not replaced)
Comparator
Craniotomy (bone flap replaced)
Outcomes
Primary: Extended Glasgow Outcome Scale (GOSE) rating at 12 months; Secondary: GOSE at 6 months, EQ-5D-5L scores, mortality, additional cranial surgery, wound complications
Design
Type
Multicenter, randomized, controlled trial
Randomized
Yes
Multicenter
Yes
Blinded
Outcome adjudicators blinded; clinicians and patients unblinded
Follow-up
12 months
Primary endpoint
Ordinal GOSE rating at 12 months
Secondary endpoints
- GOSE rating at 6 months
- EQ-5D-5L utility index scores
- Additional cranial surgery within 2 weeks
- Wound complications