Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma

Surgery Clinical Trial

— RESET-ASDH  

Official title:

Survival and Quality of Life After Early Surgical Intervention Versus Wait-and-see in Elderly Patients With a Traumatic Acute Subdural Hematoma (ASDH): a Pragmatic Randomized Controlled Trial With Multicenter Parallel Group Design

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04648436
• Other study ID #: NL72116.058.20/P20.005
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: June 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age = 65 years

• A GCS of = 9 and a traumatic ASDH >10 mm in diameter or a traumatic ASDH <10 mm but with a midline shift >5 mm, or a GCS <9 and a traumatic ASDH <10 mm and a midline shift <5 mm without extracranial explanations for the comatose condition

• Clinical equipoise exists (i.e. the responsible neurosurgeon is uncertain about the benefits of either treatment)

• Informed consent is obtained or deferred

Exclusion Criteria:

• Additional epidural hematoma (EDH) or infratentorial (e.g. cerebellar) intracerebral hemorrhage (ICH)

• Major traumatic abdominal or thoracic injury (each separately defined as an Abbreviated Injury Scale (AIS) score = 4) or a 'moribund' state at presentation (e.g. bilaterally absent pupillary responses)

• Known terminal condition resulting in a life expectancy of less than 1 year

Related Conditions & MeSH terms

• Hematoma
• Hemorrhage
• Intracranial Hemorrhages
• Surgery

Intervention

Other:
• Early neurosurgical hematoma evacuation
Early neurosurgical hematoma evacuation (preferably within 2 hours)
• Conservative treatment (best medical management)
Conservative treatment (best medical management) on the ICU or ward

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center (LUMC)	Leiden	Zuid Holland

Sponsors (17)

Lead Sponsor

Collaborator

Leiden University Medical Center

Algemeen Ziekenhuis Delta, Algemeen Ziekenhuis Sint-Jan Brugge, Amsterdam Universitair Medisch Centrum, Centre Hospitalier Universitaire de Liege, Elisabeth-TweeSteden Ziekenhuis, Erasme Hospital Universite Libre de Bruxelles, Erasmus Medical Center, Funding agencies: ZonMw / KCE (BeNeFIT), Haaglanden Medisch Centrum, Medisch Spectrum Twente, Radboud Universitair Medisch Centrum, Universitair Ziekenhuis Leuven, Universite Libre de Bruxelles, University Hospital, Antwerp, Utrecht Universitair Medisch Centrum, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale Extended (GOS-E)	scale of functional outcome ranging from 1-8 in which a higher score reflects a better recovery	1 year