Clinical trial NCT04648436: Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intracranial Hemorrhages
Surgery
Keywords: Neurosurgery
Acute subdural hematoma
Traumatic brain injury
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Haaglanden Medisch Centrum
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Erasmus Medical Center
name: Elisabeth-TweeSteden Ziekenhuis
name: Medisch Spectrum Twente
name: Radboud Universitair Medisch Centrum
name: Utrecht Universitair Medisch Centrum
name: Universitair Ziekenhuis Leuven
name: Algemeen Ziekenhuis Sint-Jan Brugge
name: Universite Libre de Bruxelles
name: Erasme Hospital Universite Libre de Bruxelles
name: University Hospital, Antwerp
name: Ziekenhuis Oost-Limburg
name: Centre Hospitalier Universitaire de Liege
name: Algemeen Ziekenhuis Delta
name: Funding agencies: ZonMw / KCE (BeNeFIT)
First posted: 2020-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with parallel group design
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Glasgow Outcome Scale Extended (GOS-E)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
state: Zuid Holland
Study officials:
References:
citation: Singh RD, van Dijck JTJM, van Essen TA, Lingsma HF, Polinder SS, Kompanje EJO, van Zwet EW, Steyerberg EW, de Ruiter GCW, Depreitere B, Peul WC. Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design. Trials. 2022 Mar 29;23(1):242. doi: 10.1186/s13063-022-06184-1.