Acute Subdural HematomaSMASHNCT03284190
Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study
An observational study of Acute Subdural Hematoma, run by Karolinska University Hospital.
Trial summary
In a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (< 70 y/o) with acute subdural hematoma treated surgically. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Subdural Hematoma
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2018to 1 Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgically treated patients with acute subdural hematoma
Who may be able to join
- Surgically treated ASDH patients
Who cannot join
- Post-operative ASDH (i.e. inclusion criteria post-traumatic)
- Intracranial surgery within 6 months prior to trauma
- Permanent intracranial device (i.e DBS electode, VP shunt etc.)
About this study
Official title: Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort
In a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (< 70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the clinical outcome and the prognostic factors of acute subdural hematomas would allow physicians to make better decisions about treatment options in traumatic ASDH in the elderly population.
Read the detailed description
Primary endpoint:
In a population based study to evaluate 30-day mortality (perioperative death) in younger versus elderly (≥70 years) patients with ASDH.
Secondary endpoint(s):
- Describe pattern of care in younger versus the elderly
- Clinical outcome (Glasgow outcome scale at 6-months (range, 3-12) follow-up in younger versus elderly (≥70 years) patients with ASDH:
- Good outcome predefined as GOS 4-5
- Unfavourable outcome predefined as GOS 1-3
- 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70 years) patients with ASDH.
- To assess the effect of age as an independent prognostic factor in traumatic ASDH for outcome (GOS) in the elderly (≥70 years) using a three-step approach
- Match elderly (cases) with younger (controls) patients with respect to
- GCS at admission to treating hospital according to severity - mild (GCS 14-15), moderate (GCS 9-13), severe (GCS 3-8)
- Midline-shift (with a cut off of > 10 mm)
- Dilated pupil(s) (yes/no)
- Using a multivariable approach with all patients including age (continuous model) to identify independent predictors of an unfavourable outcome (GOS 1-3)
- Using a multivariable approach including age as a continuous variable within the elderly population (≥70 years) to identify independent predictors of an unfavourable outcome among the oldest (GOS 1-3)
- Conditions
- Acute Subdural Hematoma
- Being tested
- Surgery
- Medical subject headings
- Hematoma, Subdural, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| ASDH Copenhagen, Denmark | Not described Receives: Procedure: Surgery | |
| ASDH Odense, Denmark | Not described Receives: Procedure: Surgery | |
| ASDH Århus, Denmark | Not described Receives: Procedure: Surgery | |
| ASDH Ålborg, Denmark | Not described Receives: Procedure: Surgery | |
| ASDH Lund, Sweden | Not described Receives: Procedure: Surgery | |
| ASDH Linköping, Sweden | Not described Receives: Procedure: Surgery | |
| ASDH Gothenburg, Sweden | Not described Receives: Procedure: Surgery | |
| ASDH Stockholm, Sweden | Not described Receives: Procedure: Surgery | |
| ASDH Uppsala, Sweden | Not described Receives: Procedure: Surgery | |
| ASDH Umeå, Sweden | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality (yes vs. no) in younger versus elderly
30-day mortality (yes vs. no) in younger versus elderly
Measured: 30-day mortality after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start6 Mar 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
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 Acute Subdural HematomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiri Bartek, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284190
- Sponsor's protocol ID
- SMASH
- Acronym
- SMASH
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartek J Jr, Laugesen C, Mirza S, Forsse A, Petersen MA, Corell A, Dyhrfort PW, Redebrandt HN, Reen L, Zolfaghari S, Tobieson L, Carlsvard B, Bergholt B, Bashir A, Soerensen P, Bilgin A, Johansson C, Lindvall P, Forander P, Bellander BM, Springborg JB, Jakola AS. Scandinavian Multicenter Acute Subdural Hematoma (SMASH) Study: Study Protocol for a Multinational Population-Based Consecutive Cohort. Neurosurgery. 2019 Mar 1;84(3):799-803. doi: 10.1093/neuros/nyy173.
PubMed 29762769
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort
- ClinicalTrials.gov ID
- NCT03284190
- Acronym / sponsor ID
- SMASH / SMASH
- Conditions
- Acute Subdural Hematoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 15 Sep 2017 (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.
In a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (< 70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the clinical outcome and the prognostic factors of acute subdural hematomas would allow physicians to make better decisions about treatment options in traumatic ASDH in the elderly population.
Detailed description
Primary endpoint:
In a population based study to evaluate 30-day mortality (perioperative death) in younger versus elderly (≥70 years) patients with ASDH.
Secondary endpoint(s):
- Describe pattern of care in younger versus the elderly
- Clinical outcome (Glasgow outcome scale at 6-months (range, 3-12) follow-up in younger versus elderly (≥70 years) patients with ASDH:
- Good outcome predefined as GOS 4-5
- Unfavourable outcome predefined as GOS 1-3
- 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70 years) patients with ASDH.
- To assess the effect of age as an independent prognostic factor in traumatic ASDH for outcome (GOS) in the elderly (≥70 years) using a three-step approach
- Match elderly (cases) with younger (controls) patients with respect to
- GCS at admission to treating hospital according to severity - mild (GCS 14-15), moderate (GCS 9-13), severe (GCS 3-8)
- Midline-shift (with a cut off of > 10 mm)
- Dilated pupil(s) (yes/no)
- Using a multivariable approach with all patients including age (continuous model) to identify independent predictors of an unfavourable outcome (GOS 1-3)
- Using a multivariable approach including age as a continuous variable within the elderly population (≥70 years) to identify independent predictors of an unfavourable outcome among the oldest (GOS 1-3)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| ASDH Copenhagen, Denmark | – | Procedure: Surgery |
| ASDH Odense, Denmark | – | Procedure: Surgery |
| ASDH Århus, Denmark | – | Procedure: Surgery |
| ASDH Ålborg, Denmark | – | Procedure: Surgery |
| ASDH Lund, Sweden | – | Procedure: Surgery |
| ASDH Linköping, Sweden | – | Procedure: Surgery |
| ASDH Gothenburg, Sweden | – | Procedure: Surgery |
| ASDH Stockholm, Sweden | – | Procedure: Surgery |
| ASDH Uppsala, Sweden | – | Procedure: Surgery |
| ASDH Umeå, Sweden | – | Procedure: Surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgically treated patients with acute subdural hematoma
Key inclusion criteria (1 listed)
- Surgically treated ASDH patients
Key exclusion criteria (3 listed)
- Post-operative ASDH (i.e. inclusion criteria post-traumatic)
- Intracranial surgery within 6 months prior to trauma
- Permanent intracranial device (i.e DBS electode, VP shunt etc.)
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 |
|---|---|---|
| SurgerySurgery | Procedure or surgery | ASDH Copenhagen, Denmark, ASDH Gothenburg, Sweden, ASDH Linköping, Sweden, ASDH Lund, Sweden, ASDH Odense, Denmark, ASDH Stockholm, Sweden, ASDH Umeå, Sweden, ASDH Uppsala, Sweden, ASDH Ålborg, Denmark, ASDH Århus, Denmark |
Primary outcome
30-day mortality (yes vs. no) in younger versus elderly
Time frame: 30-day mortality after surgery
30-day mortality (yes vs. no) in younger versus elderly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 29762769Bartek J Jr, Laugesen C, Mirza S, Forsse A, Petersen MA, Corell A, Dyhrfort PW, Redebrandt HN, Reen L, Zolfaghari S, Tobieson L, Carlsvard B, Bergholt B, Bashir A, Soerensen P, Bilgin A, Johansson C, Lindvall P, Forander P, Bellander BM, Springborg JB, Jakola AS. Scandinavian Multicenter Acute Subdural Hematoma (SMASH) Study: Study Protocol for a Multinational Population-Based Consecutive Cohort. Neurosurgery. 2019 Mar 1;84(3):799-803. doi: 10.1093/neuros/nyy173.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Subdural Hematoma, run by Karolinska University Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
30-day mortality (yes vs. no) in younger versus elderly (time frame: 30-day mortality after surgery). 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 NCT03284190, 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 6 Mar 2018.