Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma

NCT04648436 | Withdrawn DMC

• 1 other identifier: NL72116.058.20/P20.005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hemorrhages; Surgery

Keywords

Neurosurgery; Acute subdural hematoma; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Early surgery

OTHER

Other: Early neurosurgical hematoma evacuation

Initial conservative treatment

OTHER

Other: Conservative treatment (best medical management)

Interventions

Early neurosurgical hematoma evacuation OTHER

Early neurosurgical hematoma evacuation (preferably within 2 hours)

Early surgery

Conservative treatment (best medical management) OTHER

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

Initial conservative treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35351178 DERIVED

MeSH Terms

Conditions

Intracranial Hemorrhages; Hematoma, Subdural, Acute; Brain Injuries, Traumatic

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Craniocerebral Trauma; Trauma, Nervous System; Hematoma; Wounds and Injuries; Brain Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Neurosurgery

Model Details: Randomized controlled trial with parallel group design

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 1, 2020
• Study Start: March 1, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

NL (1)