BeNeFIT18565: Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma - RESET ASDH

Summary (French or Dutch)

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.

Trial Description
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)

Status

Open

 

Trial team

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)
Documents
Protocol  
Report

Q3/2023

Publication

 

References

Clinicaltrials.gov: pending

Webpage: 

Funding scheme