<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/NCT02258919</url>
  </required_header>
  <id_info>
    <org_study_id>163/14</org_study_id>
    <secondary_id>32003B_150009</secondary_id>
    <nct_id>NCT02258919</nct_id>
  </id_info>
  <brief_title>Decompressive Hemicraniectomy in Intracerebral Hemorrhage</brief_title>
  <acronym>SWITCH</acronym>
  <official_title>Swiss Trial of Decompressive Craniectomy Versus Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage (SWITCH): a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates&#xD;
      up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30&#xD;
      per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes&#xD;
      worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients&#xD;
      with malignant middle cerebral artery (MCA) infarction. Based on the common&#xD;
      pathophysiological mechanisms of these two conditions, this procedure is also frequently&#xD;
      performed in patients with ICH, but is has not yet been investigated in a randomized trial.&#xD;
&#xD;
      The primary objective of this randomized controlled trial is to determine whether&#xD;
      decompressive surgery and best medical treatment in patients with spontaneous ICH will&#xD;
      improve outcome compared to best medical treatment only.&#xD;
&#xD;
      Secondary objectives are to analyze mortality, dependency and quality of life. Safety&#xD;
      endpoints are to determine cause of any mortality and the rate of medical and surgical&#xD;
      complications after DC compared with best medical treatment alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates&#xD;
      up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30&#xD;
      per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes&#xD;
      worldwide each year. One-third of patients with ICH die within one month and the majority of&#xD;
      survivors remain handicapped. Neurological injury resulting from ICH is mediated by the mass&#xD;
      effect of the hematoma, secondary to brain edema and/or both mechanisms. Treatment of ICH is&#xD;
      one of the major unresolved issues of acute stroke treatment. The International Surgical&#xD;
      Trials in Intracerebral Hemorrhage (STICH and STICH II) and other randomized controlled&#xD;
      trials did not show any superiority of surgical treatment compared to conservative treatment&#xD;
      approaches. Nevertheless, surgical treatment in ICH remains a matter of debate and attempts&#xD;
      to improve outcome using surgical therapy are still ongoing. Many efforts are made to&#xD;
      minimize the invasiveness of operative procedures such as clot evacuation. However, direct&#xD;
      surgical interventions aiming at the removal of the hematoma have failed to improve&#xD;
      neurological outcome for most subtypes of ICH, especially deep-seated hematomas. The trauma&#xD;
      of open craniotomy and especially trauma to the brain parenchyma for hematoma evacuation are&#xD;
      considered to outweigh the benefits of surgery.&#xD;
&#xD;
      Decompressive craniectomy (DC), which is beneficial in patients with malignant middle&#xD;
      cerebral artery (MCA) infarction, may indirectly relieve the mass effect, decrease&#xD;
      perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve&#xD;
      outcome without further damage to the brain due to surgery. Consequently, DC has been&#xD;
      established as a standard surgical therapy for patients with malignant MCA infarction with a&#xD;
      level of evidence grade 2. Decompressive craniectomy for acute stroke is one of the most&#xD;
      effective treatments available: the number needed to be treated to save one patient's life is&#xD;
      2. Decompressive craniectomy is also a standard therapeutic procedure in patients with ICH&#xD;
      due to sinus venous thrombosis, herpes encephalitis, or ruptured intracranial aneurysms. In&#xD;
      patients with traumatic brain injury DC is a standard therapy to reduce elevated intracranial&#xD;
      pressure. The investigators and others assessed whether DC is feasible and beneficial in&#xD;
      patients with spontaneous intracranial hemorrhage. The investigators showed in a previous&#xD;
      retrospective trial that DC in patients with supratentorial ICH is safe and feasible and may&#xD;
      reduce mortality compared to matched controls with best medical treatment alone. The&#xD;
      limitations of the feasibility trial are its retrospective design, the small sample size and&#xD;
      the inhomogeneity of the patient cohort with respect to the origin of ICH. Furthermore, in&#xD;
      the feasibility trial the decision for DC was taken on an individual basis rather than&#xD;
      according to a strict protocol, introducing a potential selection bias. Nevertheless, the&#xD;
      preliminary results are encouraging. Recently, three human trials, one animal study, one&#xD;
      meta-analysis, and one original contribution have been published on this topic. However, no&#xD;
      prospective randomized trial has ever assessed whether DC without hematoma evacuation in&#xD;
      patients with acute ICH improves outcome. All recent studies showed promising results and all&#xD;
      call for the initiation of a randomized controlled trial.&#xD;
&#xD;
      Objective&#xD;
&#xD;
      The primary objective of this randomized controlled trial is to determine whether&#xD;
      decompressive surgery and best medical treatment in patients with spontaneous ICH will&#xD;
      improve outcome compared to best medical treatment only.&#xD;
&#xD;
      Secondary objectives are to analyze mortality, dependency and quality of life. Safety&#xD;
      endpoints are to determine cause of any mortality and the rate of medical and surgical&#xD;
      complications after DC compared with best medical treatment alone.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      All patients with a suspected intracerebral hemorrhage will be considered for this trial.&#xD;
      Randomization of eligible patients will be performed within 66 hours after ictus in patients&#xD;
      with stable clot volume and surgery no later than 6 hours after randomization. Patients&#xD;
      randomized to the control group will receive best medical treatment according to&#xD;
      international guidelines. Patients randomized to the treatment group will receive best&#xD;
      medical treatment and a DC of at least 12cm according to institutional guidelines and a&#xD;
      surgical protocol. The primary outcome death and dependency at 6 months will be assessed by a&#xD;
      trained person unaware of treatment allocation. Favorable outcome is defined as a modified&#xD;
      Rankin Scale (mRS) score of 0 to 4, poor outcome as modified Rankin Scale score of 5 or 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">May 23, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score in modified Rankin Scale (mRS)</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed by telephone interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>7 days, 30 days, 180 days, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRS score of 0-3 versus 4-6</measure>
    <time_frame>30 days, 180 days, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Categorical shift in mRS score</measure>
    <time_frame>180 days, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>180 days, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death and intracranial hemorrhage</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Cerebral Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Decompressive craniectomy and best medical treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decompressive craniectomy and best medical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best medical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Best medical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Decompressive craniectomy (DC) and best medical treatment</intervention_name>
    <description>Decompressive craniectomy:&#xD;
All patients in the treatment group will receive DC of at least 12 cm according to institutional guidelines and a published surgical protocol.&#xD;
Best medical treatment:&#xD;
Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.</description>
    <arm_group_label>Decompressive craniectomy and best medical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Best medical treatment</intervention_name>
    <description>Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.</description>
    <arm_group_label>Best medical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent of the patient or of patient's next of kin plus consent of an&#xD;
             independent physician if patient is unable to consent before randomization&#xD;
&#xD;
          -  Acute stroke syndrome due to a spontaneous ICH, defined as the sudden occurrence of&#xD;
             bleeding into the parenchyma of the basal ganglia and/or thalamus that may extend into&#xD;
             the ventricles and into the cerebral lobes, and into the subarachnoid space, confirmed&#xD;
             by clinical history and imaging&#xD;
&#xD;
          -  Age: ≥18 to ≤75 years&#xD;
&#xD;
          -  Glasgow coma scale (GCS) &lt;14 and &gt;7&#xD;
&#xD;
          -  Neurological deficit with a NIHSS score of ≥10 and ≤30&#xD;
&#xD;
          -  Able to be randomly assigned to surgical treatment within 66 hours after ictus&#xD;
&#xD;
          -  Surgery performed not later than 6 hours after randomization&#xD;
&#xD;
          -  Volume of hematoma ≥30 ml and ≤100 ml&#xD;
&#xD;
          -  Stable clot volume&#xD;
&#xD;
          -  International normalized ratio (INR) &lt;1.5, thrombocytes &gt;100 T/ml&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  ICH due to known or suspected structural abnormality in the brain (e.g., intracranial&#xD;
             aneurysm, brain arteriovenous malformation, brain tumor) or brain trauma, or previous&#xD;
             stroke thrombolysis&#xD;
&#xD;
          -  Cerebellar or brainstem hemorrhage&#xD;
&#xD;
          -  Exclusive lobar hemorrhage&#xD;
&#xD;
          -  Known advanced dementia or significant pre-stroke disability&#xD;
&#xD;
          -  Concomitant medical illness that would interfere with outcome assessment and follow-up&#xD;
&#xD;
          -  Randomization not possible within 66 hours after ictus&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prior major brain surgery within &lt;6 month or prior DC&#xD;
&#xD;
          -  Foreseeable difficulties in follow-up due to geographic reasons&#xD;
&#xD;
          -  Known definite contraindication for a surgical procedure&#xD;
&#xD;
          -  A very high likelihood that the patient will die within the next 24 hours on the basis&#xD;
             of clinical and/or radiological criteria&#xD;
&#xD;
          -  Previous participation in this trial or in another ongoing investigational trial&#xD;
&#xD;
          -  Prior symptomatic ICH&#xD;
&#xD;
          -  ICH secondary to thrombolysis&#xD;
&#xD;
          -  Bilateral areactive pupils&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urs Fischer, Prof. Dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>Dep. of Neurology, Inselspital Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jürgen Beck, Prof. Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Dep. of Neurosurgery, Inselspital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinik für Neurochirurgie, Kepler Universitätsklinikum Linz</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Universitätsklinikum Schleswig Holstein</name>
      <address>
        <city>Lübeck</city>
        <state>Schleswig Holstein</state>
        <zip>23562</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirugie, Helios Klinikum Erfurt</name>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie Uniklinik RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurosurgery, Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Neurochirurgie, Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Universitätsklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Klinik, Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Universitätsklinikum Essen (AöR)</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum der Neurologie und Neurochirurgie, Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Universitätsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurochirurgische Klinik, Universitätsklinikum Gießen und Marburg UKGM</name>
      <address>
        <city>Gießen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Universitätsmedizin Göttingen</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Klinikum Kassel</name>
      <address>
        <city>Kassel</city>
        <zip>34125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurochirurgische Klinik, Universitätsmedizin Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurochirurgische Klinik, Universitätsklinikum Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dep. of Neurosurgery, Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Allgemeine Neurologie, Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Neurochirurgie, Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center Amsterdam, Department of Neurology</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht, Department of Neurology, Department of Neurosurgery</name>
      <address>
        <city>Utrecht</city>
        <zip>3584</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicio de Neurocirurgía Bellvitge Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicio de Neurología, Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicios de Neurología, Neurocirugía y Cuidados Intensivos del Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dep. of Neurology / Dep. of Neurosurgery, Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dep. of Clinical Neuroscience, Service of Neurosurgery</name>
      <address>
        <city>Geneva</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dep. Neurosurgery, Ospedale Regionale di Lugano</name>
      <address>
        <city>Lugano</city>
        <zip>6903</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dep. of Neurosurgery, University Hospital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>Sweden</country>
  </removed_countries>
  <link>
    <url>http://www.switch-trial.ch</url>
    <description>Website of the trial</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intracerebral hemorrhage</keyword>
  <keyword>Decompressive craniectomy</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Acute stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT02258919
org study id: 163/14
secondary id: 32003B_150009
nct id: NCT02258919
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates
      up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30
      per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes
      worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients
      with malignant middle cerebral artery (MCA) infarction. Based on the common
      pathophysiological mechanisms of these two conditions, this procedure is also frequently
      performed in patients with ICH, but is has not yet been investigated in a randomized trial.

      The primary objective of this randomized controlled trial is to determine whether
      decompressive surgery and best medical treatment in patients with spontaneous ICH will
      improve outcome compared to best medical treatment only.

      Secondary objectives are to analyze mortality, dependency and quality of life. Safety
      endpoints are to determine cause of any mortality and the rate of medical and surgical
      complications after DC compared with best medical treatment alone.
Background

      Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates
      up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30
      per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes
      worldwide each year. One-third of patients with ICH die within one month and the majority of
      survivors remain handicapped. Neurological injury resulting from ICH is mediated by the mass
      effect of the hematoma, secondary to brain edema and/or both mechanisms. Treatment of ICH is
      one of the major unresolved issues of acute stroke treatment. The International Surgical
      Trials in Intracerebral Hemorrhage (STICH and STICH II) and other randomized controlled
      trials did not show any superiority of surgical treatment compared to conservative treatment
      approaches. Nevertheless, surgical treatment in ICH remains a matter of debate and attempts
      to improve outcome using surgical therapy are still ongoing. Many efforts are made to
      minimize the invasiveness of operative procedures such as clot evacuation. However, direct
      surgical interventions aiming at the removal of the hematoma have failed to improve
      neurological outcome for most subtypes of ICH, especially deep-seated hematomas. The trauma
      of open craniotomy and especially trauma to the brain parenchyma for hematoma evacuation are
      considered to outweigh the benefits of surgery.

      Decompressive craniectomy (DC), which is beneficial in patients with malignant middle
      cerebral artery (MCA) infarction, may indirectly relieve the mass effect, decrease
      perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve
      outcome without further damage to the brain due to surgery. Consequently, DC has been
      established as a standard surgical therapy for patients with malignant MCA infarction with a
      level of evidence grade 2. Decompressive craniectomy for acute stroke is one of the most
      effective treatments available: the number needed to be treated to save one patient's life is
      2. Decompressive craniectomy is also a standard therapeutic procedure in patients with ICH
      due to sinus venous thrombosis, herpes encephalitis, or ruptured intracranial aneurysms. In
      patients with traumatic brain injury DC is a standard therapy to reduce elevated intracranial
      pressure. The investigators and others assessed whether DC is feasible and beneficial in
      patients with spontaneous intracranial hemorrhage. The investigators showed in a previous
      retrospective trial that DC in patients with supratentorial ICH is safe and feasible and may
      reduce mortality compared to matched controls with best medical treatment alone. The
      limitations of the feasibility trial are its retrospective design, the small sample size and
      the inhomogeneity of the patient cohort with respect to the origin of ICH. Furthermore, in
      the feasibility trial the decision for DC was taken on an individual basis rather than
      according to a strict protocol, introducing a potential selection bias. Nevertheless, the
      preliminary results are encouraging. Recently, three human trials, one animal study, one
      meta-analysis, and one original contribution have been published on this topic. However, no
      prospective randomized trial has ever assessed whether DC without hematoma evacuation in
      patients with acute ICH improves outcome. All recent studies showed promising results and all
      call for the initiation of a randomized controlled trial.

      Objective

      The primary objective of this randomized controlled trial is to determine whether
      decompressive surgery and best medical treatment in patients with spontaneous ICH will
      improve outcome compared to best medical treatment only.

      Secondary objectives are to analyze mortality, dependency and quality of life. Safety
      endpoints are to determine cause of any mortality and the rate of medical and surgical
      complications after DC compared with best medical treatment alone.

      Methods

      All patients with a suspected intracerebral hemorrhage will be considered for this trial.
      Randomization of eligible patients will be performed within 66 hours after ictus in patients
      with stable clot volume and surgery no later than 6 hours after randomization. Patients
      randomized to the control group will receive best medical treatment according to
      international guidelines. Patients randomized to the treatment group will receive best
      medical treatment and a DC of at least 12cm according to institutional guidelines and a
      surgical protocol. The primary outcome death and dependency at 6 months will be assessed by a
      trained person unaware of treatment allocation. Favorable outcome is defined as a modified
      Rankin Scale (mRS) score of 0 to 4, poor outcome as modified Rankin Scale score of 5 or 6.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Score in modified Rankin Scale (mRS)
time frame: 6 months
description: Assessed by telephone interview
measure: Mortality
time frame: 7 days, 30 days, 180 days, 12 months
measure: mRS score of 0-3 versus 4-6
time frame: 30 days, 180 days, 12 months
measure: Categorical shift in mRS score
time frame: 180 days, 12 months
measure: Quality of life
time frame: 180 days, 12 months
measure: Death and intracranial hemorrhage
time frame: intraoperative
arm group label: Decompressive craniectomy and best medical treatment
arm group type: Experimental
description: Decompressive craniectomy and best medical treatment
arm group label: Best medical treatment
arm group type: Active Comparator
description: Best medical treatment
intervention type: Procedure
intervention name: Decompressive craniectomy (DC) and best medical treatment
description: Decompressive craniectomy:
All patients in the treatment group will receive DC of at least 12 cm according to institutional guidelines and a published surgical protocol.
Best medical treatment:
Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.
arm group label: Decompressive craniectomy and best medical treatment
intervention type: Procedure
intervention name: Best medical treatment
description: Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.
arm group label: Best medical treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Urs Fischer, Prof. Dr. med.
role: Study Director
affiliation: Dep. of Neurology, Inselspital Bern
last name: Jürgen Beck, Prof. Dr. med.
role: Study Chair
affiliation: Dep. of Neurosurgery, Inselspital Bern
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country: Austria
country: Belgium
country: Finland
country: France
country: Germany
country: Netherlands
country: Spain
country: Switzerland
country: Sweden
url: http://www.switch-trial.ch
description: Website of the trial
responsible party type: Sponsor
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage