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Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study

Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03284190
Acronym
SMASH
Enrollment
1600
Registered
2017-09-15
Start date
2018-03-06
Completion date
2018-12-01
Last updated
2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Subdural Hematoma

Brief 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. 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): 1. Describe pattern of care in younger versus the elderly 2. 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 3. 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70 years) patients with ASDH. 4. 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 1. Match elderly (cases) with younger (controls) patients with respect to 1. GCS at admission to treating hospital according to severity - mild (GCS 14-15), moderate (GCS 9-13), severe (GCS 3-8) 2. Midline-shift (with a cut off of \> 10 mm) 3. Dilated pupil(s) (yes/no) 2. Using a multivariable approach with all patients including age (continuous model) to identify independent predictors of an unfavourable outcome (GOS 1-3) 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)

Interventions

PROCEDURESurgery

Surgery

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Surgically treated ASDH patients

Exclusion criteria

* 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.)

Design outcomes

Primary

MeasureTime frameDescription
30-day mortality (yes vs. no) in younger versus elderly30-day mortality after surgery30-day mortality (yes vs. no) in younger versus elderly

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026