Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study

Karolinska University Hospital

Status: Unknown

Conditions: Acute Subdural Hematoma

Treatments: Procedure: Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03284190

SMASH

Details and patient eligibility

About

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.

Full 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)

Enrollment: 1,600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

1,600 participants in 10 patient groups

ASDH Copenhagen, Denmark

Treatment:

Procedure: Surgery

ASDH Odense, Denmark

Treatment:

Procedure: Surgery

ASDH Århus, Denmark

Treatment:

Procedure: Surgery

ASDH Ålborg, Denmark

Treatment:

Procedure: Surgery

ASDH Lund, Sweden

Treatment:

Procedure: Surgery

ASDH Linköping, Sweden

Treatment:

Procedure: Surgery

ASDH Gothenburg, Sweden

Treatment:

Procedure: Surgery

ASDH Stockholm, Sweden

Treatment:

Procedure: Surgery

ASDH Uppsala, Sweden

Treatment:

Procedure: Surgery

ASDH Umeå, Sweden

Treatment:

Procedure: Surgery