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 many 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. Therefore, there is a need 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.
| Title |
Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET ASDH Study) |
|
Participants (P) |
Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a traumatic ASDH >10 mm or a traumatic 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 explanations for the comatose state, for whom clinical equipoise exists regarding the preferred treatment. |
|
Intervention (I) |
Early surgical hematoma evacuation (A). The exact neurosurgical technique will be left to the discretion of the surgeons. |
|
Control (C) |
Conservative management on the ICU or the ward (B). In case of neurological deterioration during conservative management, delayed surgery can be performed. |
|
Outcome (O) |
Functional outcome after 1 year, expressed by the rating on the Extended Glasgow Outcome Scale (GOS-E) |
|
Trial Design |
A prospective, pragmatic, multicenter, randomized controlled trial (RCT). |
|
Sample Size |
300 patients |
|
Trial duration |
40 months |
|
Budget |
€1.7M (€0.55M in Bel) |
|
Sponsor |
International study sponsor : Leiden University Medical Center Belgian Coordinating Center: UZ Leuven |
|
Chief Investigator |
Prof. Dr. Wilco Peul BCC: Prof. Dr. Bart Depreitere
|
|
Sites |
12 Hospitals (6 in Belgium and 6 in The Netherlands) |
| Protocol | View publication Trials |
| Results | View publication Brain and spine |
For timelines and recruitment, see dashboard
Clinicaltrials.gov: NCT04648436
Webpage:
