BeNeFIT18565: Randomisierte Bewertung der chirurgischen Intervention bei älteren Patienten (ab 65 Jahren) mit traumatischem akuten subduralen Hämatom - RESET-Studie

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)
Dokumente
Protocol  
Report

Q3/2023

Publication

 

REFERENZEN

Clinicaltrials.gov: pending

Webpage: 

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