Background: An intracranial hematoma, specifically an acute subdural hematoma (ASDH), is a common and increasing injury in elderly TBI patients (=or> 65 years old), accompanied by huge medical and economic consequences. Uncertainty about the surgical versus conservative treatment remains a clinical and moral dilemma. Current guidelines are not based on high-quality evidence and compliance is low, allowing large treatment variation. Also, elderly are underrepresented in literature and guidelines which increases uncertainty in (neurosurgical) decision-making. As participants in CENTER-TBI and Net-QuRe studies, the investigators observe that the uncertainty regarding treatment decisions will not be solved after completion. Therefore, they propose this prospective, randomized, multicenter trial on the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly with a traumatic ASDH.
Methods: 300 elderly patients with a GCS =or> 9 sustaining a traumatic ASDH >10 mm or a traumatic ASDH < 10 mm but with a midline shift >5 mm or a GCS < 9 with a traumatic ASDH <10 mm and a midline shift <5 mm without extracranial explanation for the comatose state, presenting to the LUMC, HMC, HAGA, EMC, MST, RUMC or the UZL, UCL, ULB, SJB, ZOL and UZA from 01/01/2020 until 01/01/2022 will be randomized between early neurosurgical hematoma evacuation or a conservative treatment, provided that clinical equipoise exists. Follow up will be performed with live visits from research nurses at 3,6 and 12 months. After that, annual follow up will be by postal or by telephone for up to 5 years after the injury.
Results: The primary outcome is the GOS-E after 1 year. Secondary outcomes are the GOS-E besides the one year measurement, QOLIBRI, EQ-5D-5L, MOCA, mortality, secondary operations, costs, duration of hospital stay, complications and discharge locations. Moreover, a cost-effectiveness and cost-utility analysis will be performed.