<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/NCT04434807</url>
  </required_header>
  <id_info>
    <org_study_id>MBC2001</org_study_id>
    <nct_id>NCT04434807</nct_id>
  </id_info>
  <brief_title>Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment</brief_title>
  <acronym>EVACUATE</acronym>
  <official_title>Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Melbourne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Melbourne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus&#xD;
      standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the&#xD;
      emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage&#xD;
      &gt;20mL volume will be assessed to determine their eligibility for randomization into the&#xD;
      trial. If the patient gives informed consent they will be randomized 50:50 using central&#xD;
      computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope&#xD;
      and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is&#xD;
      prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3&#xD;
      transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis&#xD;
      of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be&#xD;
      performed when 160 patients have completed 6 month follow-up (minimum sample size 240,&#xD;
      maximum sample size 434).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>
    <intervention_model_description>Patients will receive either minimally invasive hematoma evacuation or standard medical therapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The primary outcome of Modified Rankin scale (mRS) and secondary outcomes including National Institutes of Health Stroke Scale (NIHSS) are assessed by a blinded clinician.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)</measure>
    <time_frame>6 months post-stroke</time_frame>
    <description>Modified Rankin Scale (mRS) 0-3 at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dichotomized Modified Rankin Scale Score 0-2 or no change from baseline vs. 3-6 at 6 months post-onset (adjusted)</measure>
    <time_frame>6 months post-stroke</time_frame>
    <description>Modified Rankin Scale (mRS) 0-2 or no change from baseline at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ordinal analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)</measure>
    <time_frame>6 months post-stroke</time_frame>
    <description>Ordinal analysis of Modified Rankin Scale Score (merging mRS 5-6) at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-weighted analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)</measure>
    <time_frame>6 months post-stroke</time_frame>
    <description>Utility-weighted analysis of Modified Rankin Scale Score at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in hematoma volume at 24 hours &gt;70% or &lt;15mL residual volume (adjusted)</measure>
    <time_frame>24 hours post-randomization</time_frame>
    <description>Reduction in hematoma volume at 24 hours &gt;70% or &lt;15mL residual volume, adjusted for immediate pre-treatment ICH volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with early neurological improvement at 7 days (adjusted)</measure>
    <time_frame>7 days post-stroke</time_frame>
    <description>Proportion of patients with ≥8 point reduction in National Institutes of Health Stroke Scale (NIHSS) score or reaching 0-1 at 7 days (or at discharge if earlier) adjusted for baseline NIHSS and age</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety: Death due to any cause at 6 months (adjusted)</measure>
    <time_frame>6 months post-stroke</time_frame>
    <description>Death due to any cause at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety: Hematoma growth or reaccumulation at 24 hours</measure>
    <time_frame>24 hours post-randomization</time_frame>
    <description>Hematoma growth or reaccumulation defined as &gt;33% or &gt;6mL increased volume between baseline and 24 hour scans (or in the intervention arm a hematoma volume on the follow-up scan exceeding the immediate pre-treatment volume), adjusted for the pre-treatment ICH volume.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intermediate outcome measure (primary outcome measure for Phase 2b component): Reduction in hematoma volume at 24 hours &gt;70% or &lt;15mL residual volume (adjusted)</measure>
    <time_frame>24 hours post-randomization</time_frame>
    <description>Intermediate outcome measure (primary outcome measure for the Phase 2b component to be analysed for the first 52 patients): Reduction in hematoma volume at 24 hours &gt;70% or &lt;15mL residual volume, adjusted for immediate pre-treatment ICH volume</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported Outcomes Measurement Information System (PROMIS10)</measure>
    <time_frame>6 and 12 months post-stroke</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Modified Rankin Scale (mRS) 0-2, 0-3, ordinal and utility-weighted analysis at 12 months</measure>
    <time_frame>12 months post-stroke</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Quality of Life (EQ5D) at 12 months</measure>
    <time_frame>12 months post-stroke</time_frame>
    <description>Assessment of Quality of Life (EQ5D) at 12 months (mapped to mRS at baseline)</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of stay in intensive care unit, acute hospital, acute hospital and rehabilitation</measure>
    <time_frame>6 months post-stroke</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Home time - time spent at home in the first 6 months</measure>
    <time_frame>6 months post-stroke</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Intra Cerebral Hemorrhage</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Minimally invasive hematoma evacuation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to minimally invasive hematoma evacuation will have neurosurgery followed by standard medical therapy in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care (medical therapy)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition, with no planned surgical intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimally invasive hematoma evacuation</intervention_name>
    <description>Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)</description>
    <arm_group_label>Minimally invasive hematoma evacuation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume&#xD;
&#xD;
          2. Age ≥18 years&#xD;
&#xD;
          3. Surgery can commence within 8 hours of symptom onset (the time the patient was last&#xD;
             known to be well) or, in patients with wake-up onset, within 8 hours of the time the&#xD;
             patient awoke with symptoms. Patients presenting with small ICH (volume &lt;20mL) with&#xD;
             clinical deterioration judged due to ICH hematoma expansion meeting volume criteria&#xD;
             may be randomized if surgery can commence within 8 hours of clinical deterioration&#xD;
&#xD;
          4. Moderate neurological deficit (NIHSS≥6)&#xD;
&#xD;
          5. Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance&#xD;
             and able to manage alone for at least 1 week).&#xD;
&#xD;
          6. CTA or MRA is performed and does not show an underlying vascular lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Brainstem ICH&#xD;
&#xD;
          2. ICH secondary to trauma, where brain injury is judged more likely to be due to the&#xD;
             broad effects of trauma rather than the focal ICH.&#xD;
&#xD;
          3. Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in&#xD;
             liver disease, INR&gt;1.4).&#xD;
&#xD;
          4. Platelet count &lt;75,000&#xD;
&#xD;
          5. Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be&#xD;
             ≤1.4 before procedure commences. Reversal of heparin by protamine, dabigatran by&#xD;
             idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available)&#xD;
             is permitted. Unreversed anticoagulation with a last dose within 48 hours is an&#xD;
             exclusion.&#xD;
&#xD;
          6. Recent (&lt;12 hours) parenteral GPIIb/IIIa antagonist.&#xD;
&#xD;
          7. Recent (&lt;1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours&#xD;
             following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be&#xD;
             administered prior to treatment.&#xD;
&#xD;
          8. Participation in any investigational study in the last 30 days&#xD;
&#xD;
          9. Pregnant women (clinically evident)&#xD;
&#xD;
         10. Co-morbidities or advance care directive preventing general anaesthesia for the&#xD;
             procedure.&#xD;
&#xD;
         11. Known terminal illness such that the patients would not be expected to survive a year.&#xD;
&#xD;
         12. Planned withdrawal of care or comfort care measures.&#xD;
&#xD;
         13. Any condition that, in the judgment of the investigator could impose hazards to the&#xD;
             patient if study therapy is initiated or affect the participation of the patient in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy Kleinig</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Adelaide Hospital/University of Adelaide</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amal Abou-Hamden</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Adelaide Hospital/University of Adelaide</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Laidlaw</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Melbourne Hospital/University of Melbourne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>J Mocco</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine, Mt Sinai Hospital, New York</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Kellner</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine, Mt Sinai Hospital, New York</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Davis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Melbourne Hospital/University of Melbourne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruce Campbell</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Melbourne Hospital/University of Melbourne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melbourne Brain Centre at the Royal Melbourne Hospital</last_name>
    <phone>+61 3 9342 4424</phone>
    <email>info@thembc.org.au</email>
  </overall_contact>
  <location>
    <facility>
      <name>John Hunter Hospital</name>
      <address>
        <city>Newcastle</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Russell, RN</last_name>
      <phone>+61 2 4921 3481</phone>
      <email>michelle.russell@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Carlos Garcia-Esperon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fanfan Tian</last_name>
      <phone>+61 2 9382 8891</phone>
      <email>huiqiao.tian@unsw.edu.au</email>
    </contact>
    <investigator>
      <last_name>Ken Butcher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kylie Tastula</last_name>
      <phone>+61 2 9515 4596</phone>
      <email>Kylie.Tastula@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>John Worthington</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Mark Dexter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Tran</last_name>
      <phone>+61 2 8738 7170</phone>
      <email>Lisa.Tran@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Dennis Cordato</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liam Maclachlan</last_name>
      <phone>+61 7 3365 1111</phone>
      <email>liam.maclachlan@health.qld.gov.au</email>
    </contact>
    <investigator>
      <last_name>Hamish Alexander</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jeff Webster</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Cottam</last_name>
      <phone>+61 7 5687 6395</phone>
      <email>Victoria.Cottam@health.qld.gov.au</email>
    </contact>
    <investigator>
      <last_name>Peter Bailey</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Cranefield, RN</last_name>
      <phone>+61 8 7074 2900</phone>
      <email>jennifer.cranefield@sa.gov.au</email>
    </contact>
    <investigator>
      <last_name>Timothy Kleinig</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Moore, RN</last_name>
      <phone>+61 3 9903 8655</phone>
      <email>andrea.moore@alfred.org.au</email>
    </contact>
    <investigator>
      <last_name>Geoffrey Cloud</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Austin Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dennis Young, RN</last_name>
      <phone>+61 3 9496 4953</phone>
      <email>dennis.young@austin.org.au</email>
    </contact>
    <investigator>
      <last_name>Vincent Thijs</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>May Chong, RN</last_name>
      <phone>+61 3 9594 3836</phone>
      <email>Mee.Chong@monashhealth.org</email>
    </contact>
    <investigator>
      <last_name>Henry Ma</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy McDonald, RN</last_name>
      <phone>+61 3 9342 4424</phone>
      <email>amy.mcdonald@mh.org.au</email>
    </contact>
    <investigator>
      <last_name>Bruce Campbell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Melbourne</investigator_affiliation>
    <investigator_full_name>Bruce Campbell</investigator_full_name>
    <investigator_title>Professorial Fellow, Department of Medicine, Royal Melbourne Hospital, Faculty of Medicine, Dentistry and Health Sciences</investigator_title>
  </responsible_party>
  <keyword>neurosurgery</keyword>
  <keyword>minimally invasive</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient data will be uploaded to the Virtual Stroke Trials Archive (http://www.virtualtrialsarchives.org/vista/) 2 years after the publication of the primary manuscript. Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.</ipd_description>
    <ipd_time_frame>2 years after the publication of the primary manuscript</ipd_time_frame>
    <ipd_access_criteria>Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.</ipd_access_criteria>
  </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/NCT04434807
org study id: MBC2001
nct id: NCT04434807
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus
      standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the
      emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage
      >20mL volume will be assessed to determine their eligibility for randomization into the
      trial. If the patient gives informed consent they will be randomized 50:50 using central
      computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope
      and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is
      prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3
      transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis
      of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be
      performed when 160 patients have completed 6 month follow-up (minimum sample size 240,
      maximum sample size 434).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will receive either minimally invasive hematoma evacuation or standard medical therapy
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The primary outcome of Modified Rankin scale (mRS) and secondary outcomes including National Institutes of Health Stroke Scale (NIHSS) are assessed by a blinded clinician.
measure: Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)
time frame: 6 months post-stroke
description: Modified Rankin Scale (mRS) 0-3 at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.
measure: Dichotomized Modified Rankin Scale Score 0-2 or no change from baseline vs. 3-6 at 6 months post-onset (adjusted)
time frame: 6 months post-stroke
description: Modified Rankin Scale (mRS) 0-2 or no change from baseline at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume
measure: Ordinal analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)
time frame: 6 months post-stroke
description: Ordinal analysis of Modified Rankin Scale Score (merging mRS 5-6) at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume
measure: Utility-weighted analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)
time frame: 6 months post-stroke
description: Utility-weighted analysis of Modified Rankin Scale Score at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume
measure: Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)
time frame: 24 hours post-randomization
description: Reduction in hematoma volume at 24 hours >70% or <15mL residual volume, adjusted for immediate pre-treatment ICH volume
measure: Proportion of patients with early neurological improvement at 7 days (adjusted)
time frame: 7 days post-stroke
description: Proportion of patients with ≥8 point reduction in National Institutes of Health Stroke Scale (NIHSS) score or reaching 0-1 at 7 days (or at discharge if earlier) adjusted for baseline NIHSS and age
measure: Safety: Death due to any cause at 6 months (adjusted)
time frame: 6 months post-stroke
description: Death due to any cause at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.
measure: Safety: Hematoma growth or reaccumulation at 24 hours
time frame: 24 hours post-randomization
description: Hematoma growth or reaccumulation defined as >33% or >6mL increased volume between baseline and 24 hour scans (or in the intervention arm a hematoma volume on the follow-up scan exceeding the immediate pre-treatment volume), adjusted for the pre-treatment ICH volume.
measure: Intermediate outcome measure (primary outcome measure for Phase 2b component): Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)
time frame: 24 hours post-randomization
description: Intermediate outcome measure (primary outcome measure for the Phase 2b component to be analysed for the first 52 patients): Reduction in hematoma volume at 24 hours >70% or <15mL residual volume, adjusted for immediate pre-treatment ICH volume
measure: Patient Reported Outcomes Measurement Information System (PROMIS10)
time frame: 6 and 12 months post-stroke
measure: Modified Rankin Scale (mRS) 0-2, 0-3, ordinal and utility-weighted analysis at 12 months
time frame: 12 months post-stroke
measure: Assessment of Quality of Life (EQ5D) at 12 months
time frame: 12 months post-stroke
description: Assessment of Quality of Life (EQ5D) at 12 months (mapped to mRS at baseline)
measure: Length of stay in intensive care unit, acute hospital, acute hospital and rehabilitation
time frame: 6 months post-stroke
measure: Home time - time spent at home in the first 6 months
time frame: 6 months post-stroke
arm group label: Minimally invasive hematoma evacuation
arm group type: Experimental
description: Patients randomized to minimally invasive hematoma evacuation will have neurosurgery followed by standard medical therapy in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition.
arm group label: Standard care (medical therapy)
arm group type: No Intervention
description: Patients randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition, with no planned surgical intervention.
intervention type: Procedure
intervention name: Minimally invasive hematoma evacuation
description: Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
arm group label: Minimally invasive hematoma evacuation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy Kleinig
role: Principal Investigator
affiliation: Royal Adelaide Hospital/University of Adelaide
last name: Amal Abou-Hamden
role: Principal Investigator
affiliation: Royal Adelaide Hospital/University of Adelaide
last name: John Laidlaw
role: Principal Investigator
affiliation: Royal Melbourne Hospital/University of Melbourne
last name: J Mocco
role: Principal Investigator
affiliation: Icahn School of Medicine, Mt Sinai Hospital, New York
last name: Christopher Kellner
role: Principal Investigator
affiliation: Icahn School of Medicine, Mt Sinai Hospital, New York
last name: Stephen Davis
role: Principal Investigator
affiliation: Royal Melbourne Hospital/University of Melbourne
last name: Bruce Campbell
role: Principal Investigator
affiliation: Royal Melbourne Hospital/University of Melbourne
last name: Melbourne Brain Centre at the Royal Melbourne Hospital
phone: +61 3 9342 4424
email: info@thembc.org.au
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status: Recruiting
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country: Australia
responsible party type: Principal Investigator
investigator affiliation: University of Melbourne
investigator full name: Bruce Campbell
investigator title: Professorial Fellow, Department of Medicine, Royal Melbourne Hospital, Faculty of Medicine, Dentistry and Health Sciences
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: Anonymized individual patient data will be uploaded to the Virtual Stroke Trials Archive (http://www.virtualtrialsarchives.org/vista/) 2 years after the publication of the primary manuscript. Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.
ipd time frame: 2 years after the publication of the primary manuscript
ipd access criteria: Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.