Survival and quality of life after early surgical intervention versus wait-and-see in elderly patients with a traumatic acute subdural hematoma (ASDH): a pragmatic randomized controlled trial with multicenter parallel group design

eiden University Medical Center0 sites300 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

eiden University Medical Center

•Age \= 65 years
•\-A GCS of \= 9 and a traumatic ASDH \>10 mm in diameter or a traumatic ASDH \<10 mm but with a midline shift \>5 mm, or a GCS \<9 and a traumatic ASDH \<10 mm and a midline shift \<5 mm without extracranial explanations for the comatose condition
•\-Clinical equipoise exists (i.e. the responsible neurosurgeon is uncertain about the benefits of either treatment)
•\-Informed consent is obtained or deferred

•\-Additional epidural hematoma (EDH) or infratentorial (e.g. cerebellar) intracerebral hemorrhage (ICH)
•\-Major traumatic abdominal or thoracic injury (each separately defined as an Abbreviated Injury Scale (AIS) score \= 4\) or a ‘moribund’ state at presentation (e.g. bilaterally absent pupillary responses)
•\-Known terminal condition resulting in a life expectancy of less than 1 year

Not specified