Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma (RESET-ASDH)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Surgery; Intracranial Hemorrhages
• Intervention / Treatment: Other: Early neurosurgical hematoma evacuation; Other: Conservative treatment (best medical management)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ranjit Singh, MD, MsC; Phone Number: 0682548283; Email: r.d.singh@lumc.nl

Study Locations

• Netherlands
  • Zuid Holland
    • Leiden, Zuid Holland, Netherlands, 2333ZA
      • Leiden University Medical Center (LUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Early surgery	Other: Early neurosurgical hematoma evacuation; Early neurosurgical hematoma evacuation (preferably within 2 hours)
Other: Initial conservative treatment	Other: Conservative treatment (best medical management); Conservative treatment (best medical management) on the ICU or ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Neurosurgery; Acute subdural hematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhage, Traumatic; Hemorrhage; Intracranial Hemorrhages; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Acute
• Other Study ID Numbers: NL72116.058.20/P20.005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No