(Niederländisch oder Französisch oder Englisch)
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) |
(Niederländisch oder Französisch oder Englisch)
Protocol | click here |
Report | Q3/2023 |
Publication |
Clinicaltrials.gov: NCT04648436
Webpage: