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

Abstract

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.

Does the Timing of the Surgery Have a Major Role in Influencing the Outcome in Elders with Acute Subdural Hematomas?

“…However, survival and good functional outcome remain poor in many elderly patients, despite an aggressive treatment [ 14 , 15 , 16 , 17 ]. Therefore, in this age range, the treatment of choice is still debated and the object of ongoing trials [ 6 , 7 ], and most neurosurgeons prefer an initial conservative treatment, opting for surgery only in the case of an impaired state of consciousness. Although, while surgery has also been shown to have a major life-saving role in these patients when presenting with a severe clinical status, several studies have reported a high rate of poor functional outcome both at discharge and at 6 months follow-up, often due to the higher incidence of perioperative complications [ 8 ].…”

“…In addition, the mean presenting GCS in these delayed surgery patients was rather low (12.4 ± 3.5) compared to what was expected in ASDH cases undergoing surgery. This is probably due to the awareness of the intrinsic high risk of this surgery in elderly patients [ 8 , 17 , 29 , 30 , 31 ], thus reflecting the current uncertainty of the best initial treatment in these patients [ 7 ]. Furthermore, this reflects the tendency of most neurosurgeons to choose to delay a possible craniotomy in elderly patients who do not show an initial serious clinical condition in the hope of a secondary chronicization of the hematoma, opening the possibility of its evacuation with a minimally invasive technique [ 32 , 33 ].…”

“…Traumatic ASDH in elderly patients is generally associated with a poor outcome [ 2 , 3 ]. Current guidelines on optimal treatment of these patients are based on weak evidences and, despite being considered a life-saving procedure, the role of surgery remains debated [ 4 , 5 , 6 , 7 , 8 ]. Thus, in these patients, it is quite common among clinicians preferring, at first glance, a conservative treatment, and shift toward surgery only in the case of deterioration in the state of consciousness [ 9 ].…”

Kernohan’s Notch Phenomenon in an Acute Componented Chronic Subdural Hematoma Patient: A Case Report

“…Acute subdural hematomas are intracranial hemorrhage that mortality and morbidity. 4,5 In the pathogenesis of chronic subdural hematoma, it is generally accepted that slowprogressing extra-axial hemorrhage occurs due to rupture of the bridging veins due to cerebral atopy. 6,7 The clinical findings show slow progression with the slow course of bleeding in these cases.…”

Has the Timing of the Surgery a Major Role in Influencing Outcome in Elderly Patients with Acute Subdural Hematomas?

“…For each patient, we retrieved the age, sex, Charlson Comorbidity Index (CCI), history of arterial hypertension, use of antithrombotic drugs, the need for an urgent coagulopathy correction at A&E admission, mechanism of injury, neurological status measured by the Glasgow Coma Scale (GCS) at admission and during the entire preoperative period, pupillary size and light reaction, neurological deficits, and seizures. Patients were divided in three GCS level groups, both at arrival and soon before surgery: mild (13)(14)(15), moderate (9)(10)(11)(12), and severe (3)(4)(5)(6)(7)(8).…”