Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma

Summary

Rationale: 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 most 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. In addition, elderly are underrepresented in scientific TBI literature and are therefore not included in current guidelines or prognostic models, leading to major uncertainty in (neurosurgical) decision-making for this group. As participants in two large TBI research projects (CENTER-TBI, Net-QuRe), the investigators observe that the uncertainty regarding treatment of elderly with a traumatic ASDH will not be solved by the current ongoing studies. Therefore, they recognize the necessity 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.

Objective: To compare the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly patients with a traumatic ASDH.

Study design: A prospective, pragmatic, multicenter, randomized controlled trial (RCT).

Study population: 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: Patients are randomized to either early surgical hematoma evacuation (A) or conservative management on the ICU or the ward (B). In case of neurological deterioration during conservative management, delayed surgery can be performed. The exact neurosurgical technique will be left to the discretion of the surgeons.

Main study parameters/endpoints: Functional outcome after 1 year, expressed by the rating on the Extended Glasgow Outcome Scale (GOS-E) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both treatment strategies are already used in current clinical practice as standard medical care. Therefore, there are no extra risks for patients participating in the study compared to patients outside the study. Study participation adds a minimal burden of three follow-up evaluations by visit in the first year (at 3, 6 and 12 months) and subsequent yearly evaluations by phone or postal until five years after the injury. Future elderly patients with a traumatic ASDH will benefit mostly from this study's results.

Conditions

• Intracranial Hemorrhages
• Surgery

Interventions

OTHER

Early neurosurgical hematoma evacuation

Early neurosurgical hematoma evacuation (preferably within 2 hours)

OTHER

Conservative treatment (best medical management)

Conservative treatment (best medical management) on the ICU or ward

Sponsors & Collaborators

• Haaglanden Medisch Centrum

  collaborator UNKNOWN

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Radboud Universitair Medisch Centrum

  collaborator UNKNOWN

• Utrecht Universitair Medisch Centrum

  collaborator UNKNOWN

• Universitair Ziekenhuis Leuven

  collaborator UNKNOWN

• Algemeen Ziekenhuis Sint-Jan Brugge

  collaborator UNKNOWN

• Universite Libre de Bruxelles

  collaborator UNKNOWN

• Erasme Hospital Universite Libre de Bruxelles

  collaborator UNKNOWN

• University Hospital, Antwerp

  collaborator OTHER

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• Centre Hospitalier Universitaire de Liege

  collaborator OTHER

• Algemeen Ziekenhuis Delta

  collaborator UNKNOWN

• Funding agencies: ZonMw / KCE (BeNeFIT)

  collaborator UNKNOWN

• Leiden University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2023-03-23

Completion

2023-03-23

Countries

• Netherlands

Study Locations