Clinical trial NCT03284190: Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study
Official title: Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Subdural Hematoma
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgically treated patients with 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)

Eligibility criteria: 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.)

Primary outcomes:
measure: 30-day mortality (yes vs. no) in younger versus elderly
timeFrame: 30-day mortality after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.