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Status unknownNCT03284190SMASHUpdated Mar 6, 2018

Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study

An observational study in Acute Subdural Hematoma, sponsored by Karolinska University Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2018-03-06.

Sponsored by Karolinska University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,600
Sex
All
01

Study 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.

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):

  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)
02

Conditions studied

  • Acute Subdural Hematoma
03

In context

Lead sponsor

Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.

Browse Karolinska University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Surgically treated patients with acute subdural hematoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Surgically treated ASDH patients

Exclusion criteria

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.)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,600 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureSurgery

    Surgery

06

What researchers measure

Primary outcomes

  1. 30-day mortality (yes vs. no) in younger versus elderly

    30-day mortality (yes vs. no) in younger versus elderly

    Time frame: 30-day mortality after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

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. Erratum In: Neurosurgery. 2018 Oct 1;83(4):845. doi: 10.1093/neuros/nyy381. PubMed 29762769 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03284190
Lead sponsor
Karolinska University Hospital
Responsible party
Jiri Bartek (MD, Karolinska University Hospital) — Principal investigator
First posted
Sep 15, 2017
Start date
Mar 6, 2018 (estimated)
Primary completion
Oct 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Mar 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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