Intracranial HemorrhagesRESET-ASDHNCT04648436
Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma
A study testing Early neurosurgical hematoma evacuation and Conservative treatment (best medical management) in people with Intracranial Hemorrhages and Surgery, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hemorrhages, Surgery
- What is being tested?
- Early neurosurgical hematoma evacuation and Conservative treatment (best medical management)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2022to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333ZA
About this study
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
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.
Read more
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
- Being tested
- Early neurosurgical hematoma evacuation, Conservative treatment (best medical management)
- Keywords
- Neurosurgery, Acute subdural hematoma, Traumatic brain injury
- Medical subject headings
- Intracranial Hemorrhages, Hematoma, Subdural, Acute, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early neurosurgical hematoma evacuationOther
Early neurosurgical hematoma evacuation (preferably within 2 hours)
Conservative treatment (best medical management)Other
Conservative treatment (best medical management) on the ICU or ward
| Study group | Role | What they receive |
|---|---|---|
| Early surgery | Other | Not described Receives: Other: Early neurosurgical hematoma evacuation |
| Initial conservative treatment | Other | Not described Receives: Other: Conservative treatment (best medical management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Extended (GOS-E)
scale of functional outcome ranging from 1-8 in which a higher score reflects a better recovery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Mar 2022 (estimated)
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Why it stopped: Lack of inclusion / COVID-19 regulations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Haaglanden Medisch Centrum, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Elisabeth-TweeSteden Ziekenhuis, Medisch Spectrum Twente, Radboud Universitair Medisch Centrum, Utrecht Universitair Medisch Centrum, Universitair Ziekenhuis Leuven, Algemeen Ziekenhuis Sint-Jan Brugge, Université Libre de Bruxelles, Erasme University Hospital, University Hospital, Antwerp, Ziekenhuis Oost-Limburg, Centre Hospitalier Universitaire de Liege, Algemeen Ziekenhuis Delta, Funding agencies: ZonMw / KCE (BeNeFIT)
- Responsible party
- Principal investigator, wcpeul, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648436
- Sponsor's protocol ID
- NL72116.058.20/P20.005
- Acronym
- RESET-ASDH
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2020
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35351178
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04648436
- Acronym / sponsor ID
- RESET-ASDH / NL72116.058.20/P20.005
- Conditions
- Intracranial Hemorrhages, Surgery
- Keywords
- Neurosurgery, Acute subdural hematoma, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of inclusion / COVID-19 regulations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Haaglanden Medisch Centrum, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Elisabeth-TweeSteden Ziekenhuis, Medisch Spectrum Twente, Radboud Universitair Medisch Centrum, Utrecht Universitair Medisch Centrum, Universitair Ziekenhuis Leuven, Algemeen Ziekenhuis Sint-Jan Brugge, Université Libre de Bruxelles, Erasme University Hospital, University Hospital, Antwerp, Ziekenhuis Oost-Limburg, Centre Hospitalier Universitaire de Liege, Algemeen Ziekenhuis Delta, Funding agencies: ZonMw / KCE (BeNeFIT)
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with parallel group design
| Arm | Type | Receives |
|---|---|---|
| Early surgery | Other | Other: Early neurosurgical hematoma evacuation |
| Initial conservative treatment | Other | Other: Conservative treatment (best medical management) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early neurosurgical hematoma evacuationEarly neurosurgical hematoma evacuation (preferably within 2 hours) | Other | Early surgery |
| Conservative treatment (best medical management)Conservative treatment (best medical management) on the ICU or ward | Other | Initial conservative treatment |
Primary outcome
Glasgow Outcome Scale Extended (GOS-E)
Time frame: 1 year
scale of functional outcome ranging from 1-8 in which a higher score reflects a better recovery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 35351178Singh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early neurosurgical hematoma evacuation and Conservative treatment (best medical management) in people with Intracranial Hemorrhages and Surgery, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extended (GOS-E) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.