<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03284190</url>
  </required_header>
  <id_info>
    <org_study_id>SMASH</org_study_id>
    <nct_id>NCT03284190</nct_id>
  </id_info>
  <brief_title>Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study</brief_title>
  <acronym>SMASH</acronym>
  <official_title>Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a multi-national population-based cohort, the investigators want to compare the clinical&#xD;
      course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (&lt;&#xD;
      70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the&#xD;
      clinical outcome and the prognostic factors of acute subdural hematomas would allow&#xD;
      physicians to make better decisions about treatment options in traumatic ASDH in the elderly&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary endpoint:&#xD;
&#xD;
      In a population based study to evaluate 30-day mortality (perioperative death) in younger&#xD;
      versus elderly (≥70 years) patients with ASDH.&#xD;
&#xD;
      Secondary endpoint(s):&#xD;
&#xD;
        1. Describe pattern of care in younger versus the elderly&#xD;
&#xD;
        2. Clinical outcome (Glasgow outcome scale at 6-months (range, 3-12) follow-up in younger&#xD;
           versus elderly (≥70 years) patients with ASDH:&#xD;
&#xD;
             -  Good outcome predefined as GOS 4-5&#xD;
&#xD;
             -  Unfavourable outcome predefined as GOS 1-3&#xD;
&#xD;
        3. 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70&#xD;
           years) patients with ASDH.&#xD;
&#xD;
        4. To assess the effect of age as an independent prognostic factor in traumatic ASDH for&#xD;
           outcome (GOS) in the elderly (≥70 years) using a three-step approach&#xD;
&#xD;
             1. Match elderly (cases) with younger (controls) patients with respect to&#xD;
&#xD;
                  1. GCS at admission to treating hospital according to severity - mild (GCS&#xD;
                     14-15), moderate (GCS 9-13), severe (GCS 3-8)&#xD;
&#xD;
                  2. Midline-shift (with a cut off of &gt; 10 mm)&#xD;
&#xD;
                  3. Dilated pupil(s) (yes/no)&#xD;
&#xD;
             2. Using a multivariable approach with all patients including age (continuous model)&#xD;
                to identify independent predictors of an unfavourable outcome (GOS 1-3)&#xD;
&#xD;
             3. Using a multivariable approach including age as a continuous variable within the&#xD;
                elderly population (≥70 years) to identify independent predictors of an&#xD;
                unfavourable outcome among the oldest (GOS 1-3)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 6, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>30-day mortality (yes vs. no) in younger versus elderly</measure>
    <time_frame>30-day mortality after surgery</time_frame>
    <description>30-day mortality (yes vs. no) in younger versus elderly</description>
  </primary_outcome>
  <number_of_groups>10</number_of_groups>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Acute Subdural Hematoma</condition>
  <arm_group>
    <arm_group_label>ASDH Copenhagen, Denmark</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Odense, Denmark</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Århus, Denmark</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Ålborg, Denmark</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Lund, Sweden</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Linköping, Sweden</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Gothenburg, Sweden</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Stockholm, Sweden</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Uppsala, Sweden</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ASDH Umeå, Sweden</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Surgery</description>
    <arm_group_label>ASDH Copenhagen, Denmark</arm_group_label>
    <arm_group_label>ASDH Gothenburg, Sweden</arm_group_label>
    <arm_group_label>ASDH Linköping, Sweden</arm_group_label>
    <arm_group_label>ASDH Lund, Sweden</arm_group_label>
    <arm_group_label>ASDH Odense, Denmark</arm_group_label>
    <arm_group_label>ASDH Stockholm, Sweden</arm_group_label>
    <arm_group_label>ASDH Umeå, Sweden</arm_group_label>
    <arm_group_label>ASDH Uppsala, Sweden</arm_group_label>
    <arm_group_label>ASDH Ålborg, Denmark</arm_group_label>
    <arm_group_label>ASDH Århus, Denmark</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surgically treated patients with acute subdural hematoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgically treated ASDH patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post-operative ASDH (i.e. inclusion criteria post-traumatic)&#xD;
&#xD;
          -  Intracranial surgery within 6 months prior to trauma&#xD;
&#xD;
          -  Permanent intracranial device (i.e DBS electode, VP shunt etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>March 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Jiri Bartek</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Acute</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284190
org study id: SMASH
nct id: NCT03284190
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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)
observational model: Cohort
time perspective: Retrospective
measure: 30-day mortality (yes vs. no) in younger versus elderly
time frame: 30-day mortality after surgery
description: 30-day mortality (yes vs. no) in younger versus elderly
arm group label: ASDH Copenhagen, Denmark
arm group label: ASDH Odense, Denmark
arm group label: ASDH Århus, Denmark
arm group label: ASDH Ålborg, Denmark
arm group label: ASDH Lund, Sweden
arm group label: ASDH Linköping, Sweden
arm group label: ASDH Gothenburg, Sweden
arm group label: ASDH Stockholm, Sweden
arm group label: ASDH Uppsala, Sweden
arm group label: ASDH Umeå, Sweden
intervention type: Procedure
intervention name: Surgery
description: Surgery
arm group label: ASDH Copenhagen, Denmark
arm group label: ASDH Gothenburg, Sweden
arm group label: ASDH Linköping, Sweden
arm group label: ASDH Lund, Sweden
arm group label: ASDH Odense, Denmark
arm group label: ASDH Stockholm, Sweden
arm group label: ASDH Umeå, Sweden
arm group label: ASDH Uppsala, Sweden
arm group label: ASDH Ålborg, Denmark
arm group label: ASDH Århus, Denmark
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Jiri Bartek
investigator title: MD
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Acute
mesh term: Hematoma
sharing ipd: No