Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Acute Subdural Hematoma

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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.)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASDH Copenhagen, Denmark<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Odense, Denmark<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Århus, Denmark<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Ålborg, Denmark<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Lund, Sweden<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Linköping, Sweden<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Gothenburg, Sweden<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Stockholm, Sweden<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Uppsala, Sweden<br> | Procedure: Surgery<br>* Surgery<br>|
| ASDH Umeå, Sweden<br> | Procedure: Surgery<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality (yes vs. no) in younger versus elderly | 30-day mortality (yes vs. no) in younger versus elderly | 30-day mortality after surgery |