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Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma

Leiden University Medical Center · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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naneurosurgerysurgerytraumatic-brain-injury
Rationale: The rapidly increasing number of elderly (≥ 65 years old) with traumatic brain injury (TBI) is accompanied by substantial medical and economic consequences. An intracranial hematoma, specifically an acute subdural hematoma (ASDH), is the most common injury in elderly with TBI. The surgical versus conservative treatment of this patient group remains an important clinical and moral dilemma, since it is in most cases unclear which treatment leads to a better outcome for the patient. Current guidelines are not based on high-quality evidence and compliance is low, allowing for large treatment variation in both Belgium and the Netherlands for patients with a traumatic ASDH. In addition, elderly are underrepresented in scientific TBI literature and are therefore not included in current guidelines or prognostic models, leading to major uncertainty in (neurosurgical) decision-making for this group. As participants in two large TBI research projects (CENTER-TBI, Net-QuRe), the investigators observe that the uncertainty regarding treatment of elderly with a traumatic ASDH will not be solved by the current ongoing studies. Therefore, they recognize the necessity of undertaking a prospective, randomized, multicenter trial on the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly with a traumatic ASDH. Objective: To compare the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly patients with a traumatic ASDH. Study design: A prospective, pragmatic, multicenter, randomized controlled trial (RCT). Study population: Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a traumatic ASDH \>10 mm or a traumatic ASDH \5 mm, or a GCS \< 9 with a traumatic ASDH \<10 mm and a midline shift \<5 mm without extracranial explanations for the comatose state, for whom clinical equipoise exists regarding the preferred treatment. Intervention: Pat
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