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 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•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

发起方

eiden University Medical Center