Journal Article

Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design

van Dijck, Jeroen T. J. M., van Essen, Thomas A., Singh, Ranjit D., Lingsma, Hester F., de Ruiter, Godard C. W., Kompanje, Erwin J. O., Peul, Wilco C., Polinder, Suzanne S., van Zwet, Erik W., Steyerberg, Ewout W., Depreitere, Bart

2022

Overview

Background The rapidly increasing number of elderly (≥ 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDH Methods In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and 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, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024. Discussion The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. Trial registration Nederlands Trial Register (NTR), Trial NL9012 . ClinicalTrials.gov, Trial NCT04648436 .

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Acute subdural hematoma / Aged / Anticoagulants / Biomedicine / Brain / Brain Injuries, Traumatic / Brain research / Care and treatment / Clinical trials / COVID-19 / Decision making / Elderly / Funding / Health aspects / Health Sciences / Hematoma / Hematoma, Subdural, Acute - diagnosis / Hematoma, Subdural, Acute - surgery / Humans / Injuries / Intensive care / Medical prognosis / Medicine / Medicine & Public Health / Mortality / Multicenter Studies as Topic / Neurosurgery / Neurosurgical Procedures / Neurotrauma / Older people / Patients / Pragmatic Clinical Trials as Topic / Public health / Quality of life / Randomized controlled trial / Statistics for Life Sciences / Study Protocol / Subdural hematoma / Surgery / Trauma / Trauma Centers / Traumatic brain injury