<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/NCT02995928</url>
  </required_header>
  <id_info>
    <org_study_id>TDSJWKDC</org_study_id>
    <nct_id>NCT02995928</nct_id>
  </id_info>
  <brief_title>Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage</brief_title>
  <official_title>Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tang-Du Hospital</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>
      Decompressive craniectomy has been reported for the treatment of patients with aneurysmal&#xD;
      subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been&#xD;
      undertaken to confirm its effect.The purpose of the study is to determine whether&#xD;
      decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will&#xD;
      improve clinical outcomes of poor-grade aSAH patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aneurysmal subarachnoid hemorrhage (aSAH) is a worldwide health burden with high fatality and&#xD;
      permanent disability rates. Decompressive craniectomy, which is beneficial in patients with&#xD;
      malignant middle cerebral artery 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. Early therapy with either&#xD;
      surgical clipping or neuroradiologic intervention with endovascular coiling is the primary&#xD;
      treatment for aSAH. But whether decompressive craniectomy should be employed during the&#xD;
      clipping surgery or immediately after coil embolization still have considerable controversy.&#xD;
      80 patients will be recruited to the trial over 12 months. Follow-up will take 6 months with&#xD;
      analysis and reporting taking 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Rankin scale (mRS)</measure>
    <time_frame>180 days post SAH</time_frame>
    <description>By phone call following-up by senior neurosurgeons</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin scale (mRS)</measure>
    <time_frame>30 days and 90 days post SAH</time_frame>
    <description>By phone call following-up by senior neurosurgeons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glosgow Coma Score (GCS)</measure>
    <time_frame>24 hours postoperation</time_frame>
    <description>Assessing by senior neurosurgeons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of delayed cerebral ischemia</measure>
    <time_frame>30 days post SAH</time_frame>
    <description>Proved by clinical and radiologic evidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of herniation</measure>
    <time_frame>30 days post SAH</time_frame>
    <description>Proved by clinical and radiologic evidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cerebral vasospasm</measure>
    <time_frame>30 days post SAH</time_frame>
    <description>Proved by clinical and radiologic evidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of rebleeding</measure>
    <time_frame>30 days post SAH</time_frame>
    <description>Proved by clinical and radiologic evidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>30 days post SAH</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Subarachnoid Hemorrhage, Aneurysmal</condition>
  <arm_group>
    <arm_group_label>Decompressive craniectomy</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>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure &gt;25 mm Hg for 1-12 hours to keep the patients safe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Decompressive craniectomy</intervention_name>
    <description>Decompressive craniectomy: All patients in the treatment group will receive decompressive craniectomy of at least 12 cm according to institutional guidelines and a published surgical protocol during the clipping surgery within 48 hours form the onset.</description>
    <arm_group_label>Decompressive craniectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Best medical treatment</intervention_name>
    <description>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 2012 and 2013 respectively.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Decompressive craniectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18yrs and age&lt;60yrs&#xD;
&#xD;
          -  It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on&#xD;
             admission&#xD;
&#xD;
          -  Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA),&#xD;
             magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)&#xD;
&#xD;
          -  Presentation to our institution in World Federation of Neurological Societies (WFNS)&#xD;
             Grade III to V neurological condition with Lateral hematoma&#xD;
&#xD;
          -  Duration from onset to admission is within 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic subarachnoid hemorrhage&#xD;
&#xD;
          -  Patients with cerebral herniation or highly possible to occur before surgery&#xD;
&#xD;
          -  Neurosurgery contraindicated&#xD;
&#xD;
          -  Patients with obvious evidence of acute hydrocephalus on admission&#xD;
&#xD;
          -  Intracranial aneurysm combined with cerebral arteriovenous malformation&#xD;
&#xD;
          -  Patients with obvious evidence of irreparable brainstem or thalamic injury&#xD;
&#xD;
          -  Duration from onset to admission is more than 48 hours&#xD;
&#xD;
          -  Disturbance of communication or poor compliance to blood collection, imageological&#xD;
             examination and follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yan Qu, M.D Ph.D</last_name>
    <phone>86-18629074363</phone>
    <email>yanqu0123@icloud.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Min Li, M.D Ph.D</last_name>
    <phone>86-15319053136</phone>
    <email>neursylm@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tandu Hospital, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Qu, M.D Ph.D</last_name>
      <phone>86-18629074363</phone>
      <email>yanqu0123@icloud.com</email>
    </contact>
    <contact_backup>
      <last_name>Min Li, M.D Ph.D</last_name>
      <phone>86-15319053136</phone>
      <email>neursylm@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Otani N, Takasato Y, Masaoka H, Hayakawa T, Yoshino Y, Yatsushige H, Miyawaki H, Sumiyoshi K, Chikashi A, Takeuchi S, Suzuki G. Surgical outcome following decompressive craniectomy for poor-grade aneurysmal subarachnoid hemorrhage in patients with associated massive intracerebral or Sylvian hematomas. Cerebrovasc Dis. 2008;26(6):612-7. doi: 10.1159/000165115. Epub 2008 Oct 23.</citation>
    <PMID>18946217</PMID>
  </reference>
  <reference>
    <citation>Uozumi Y, Sakowitz O, Orakcioglu B, Santos E, Kentar M, Haux D, Unterberg A. Decompressive craniectomy in patients with aneurysmal subarachnoid hemorrhage: a single-center matched-pair analysis. Cerebrovasc Dis. 2014;37(2):109-15. doi: 10.1159/000356979. Epub 2014 Feb 7.</citation>
    <PMID>24514267</PMID>
  </reference>
  <reference>
    <citation>Lu X, Huang B, Zheng J, Tao Y, Yu W, Tang L, Zhu R, Li S, Li L. Decompressive craniectomy for the treatment of malignant infarction of the middle cerebral artery. Sci Rep. 2014 Nov 17;4:7070. doi: 10.1038/srep07070.</citation>
    <PMID>25400113</PMID>
  </reference>
  <reference>
    <citation>Dorfer C, Frick A, Knosp E, Gruber A. Decompressive hemicraniectomy after aneurysmal subarachnoid hemorrhage. World Neurosurg. 2010 Oct-Nov;74(4-5):465-71. doi: 10.1016/j.wneu.2010.08.001. Epub 2011 Jan 12.</citation>
    <PMID>21492596</PMID>
  </reference>
  <reference>
    <citation>Schirmer CM, Hoit DA, Malek AM. Decompressive hemicraniectomy for the treatment of intractable intracranial hypertension after aneurysmal subarachnoid hemorrhage. Stroke. 2007 Mar;38(3):987-92. doi: 10.1161/01.STR.0000257962.58269.e2. Epub 2007 Feb 1.</citation>
    <PMID>17272765</PMID>
  </reference>
  <reference>
    <citation>Zhao B, Zhao Y, Tan X, Cao Y, Wu J, Zhong M, Wang S. Primary decompressive craniectomy for poor-grade middle cerebral artery aneurysms with associated intracerebral hemorrhage. Clin Neurol Neurosurg. 2015 Jun;133:1-5. doi: 10.1016/j.clineuro.2015.03.009. Epub 2015 Mar 14.</citation>
    <PMID>25817570</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subarachnoid Hemorrhage</keyword>
  <keyword>Decompressive Craniectomy</keyword>
  <keyword>Cerebral Aneurysm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</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/NCT02995928
org study id: TDSJWKDC
nct id: NCT02995928
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Decompressive craniectomy has been reported for the treatment of patients with aneurysmal
      subarachnoid hemorrhage (aSAH). But no prospective randomised controlled trials have yet been
      undertaken to confirm its effect.The purpose of the study is to determine whether
      decompressive craniectomy combine aneurysm clipping surgery or endovascular coiling will
      improve clinical outcomes of poor-grade aSAH patients.
Aneurysmal subarachnoid hemorrhage (aSAH) is a worldwide health burden with high fatality and
      permanent disability rates. Decompressive craniectomy, which is beneficial in patients with
      malignant middle cerebral artery 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. Early therapy with either
      surgical clipping or neuroradiologic intervention with endovascular coiling is the primary
      treatment for aSAH. But whether decompressive craniectomy should be employed during the
      clipping surgery or immediately after coil embolization still have considerable controversy.
      80 patients will be recruited to the trial over 12 months. Follow-up will take 6 months with
      analysis and reporting taking 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Modified Rankin scale (mRS)
time frame: 180 days post SAH
description: By phone call following-up by senior neurosurgeons
measure: Modified Rankin scale (mRS)
time frame: 30 days and 90 days post SAH
description: By phone call following-up by senior neurosurgeons
measure: Glosgow Coma Score (GCS)
time frame: 24 hours postoperation
description: Assessing by senior neurosurgeons
measure: Incidence of delayed cerebral ischemia
time frame: 30 days post SAH
description: Proved by clinical and radiologic evidence
measure: Incidence of herniation
time frame: 30 days post SAH
description: Proved by clinical and radiologic evidence
measure: Incidence of cerebral vasospasm
time frame: 30 days post SAH
description: Proved by clinical and radiologic evidence
measure: Incidence of rebleeding
time frame: 30 days post SAH
description: Proved by clinical and radiologic evidence
measure: Death
time frame: 30 days post SAH
arm group label: Decompressive craniectomy
arm group type: Experimental
description: Decompressive craniectomy and best medical treatment
arm group label: Control
arm group type: Active Comparator
description: Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure >25 mm Hg for 1-12 hours to keep the patients safe.
intervention type: Procedure
intervention name: Decompressive craniectomy
description: Decompressive craniectomy: All patients in the treatment group will receive decompressive craniectomy of at least 12 cm according to institutional guidelines and a published surgical protocol during the clipping surgery within 48 hours form the onset.
arm group label: Decompressive craniectomy
intervention type: Procedure
intervention name: Best medical treatment
description: 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 2012 and 2013 respectively.
arm group label: Control
arm group label: Decompressive craniectomy
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yan Qu, M.D Ph.D
phone: 86-18629074363
email: yanqu0123@icloud.com
last name: Min Li, M.D Ph.D
phone: 86-15319053136
email: neursylm@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Otani N, Takasato Y, Masaoka H, Hayakawa T, Yoshino Y, Yatsushige H, Miyawaki H, Sumiyoshi K, Chikashi A, Takeuchi S, Suzuki G. Surgical outcome following decompressive craniectomy for poor-grade aneurysmal subarachnoid hemorrhage in patients with associated massive intracerebral or Sylvian hematomas. Cerebrovasc Dis. 2008;26(6):612-7. doi: 10.1159/000165115. Epub 2008 Oct 23.
PMID: 18946217
citation: Uozumi Y, Sakowitz O, Orakcioglu B, Santos E, Kentar M, Haux D, Unterberg A. Decompressive craniectomy in patients with aneurysmal subarachnoid hemorrhage: a single-center matched-pair analysis. Cerebrovasc Dis. 2014;37(2):109-15. doi: 10.1159/000356979. Epub 2014 Feb 7.
PMID: 24514267
citation: Lu X, Huang B, Zheng J, Tao Y, Yu W, Tang L, Zhu R, Li S, Li L. Decompressive craniectomy for the treatment of malignant infarction of the middle cerebral artery. Sci Rep. 2014 Nov 17;4:7070. doi: 10.1038/srep07070.
PMID: 25400113
citation: Dorfer C, Frick A, Knosp E, Gruber A. Decompressive hemicraniectomy after aneurysmal subarachnoid hemorrhage. World Neurosurg. 2010 Oct-Nov;74(4-5):465-71. doi: 10.1016/j.wneu.2010.08.001. Epub 2011 Jan 12.
PMID: 21492596
citation: Schirmer CM, Hoit DA, Malek AM. Decompressive hemicraniectomy for the treatment of intractable intracranial hypertension after aneurysmal subarachnoid hemorrhage. Stroke. 2007 Mar;38(3):987-92. doi: 10.1161/01.STR.0000257962.58269.e2. Epub 2007 Feb 1.
PMID: 17272765
citation: Zhao B, Zhao Y, Tan X, Cao Y, Wu J, Zhong M, Wang S. Primary decompressive craniectomy for poor-grade middle cerebral artery aneurysms with associated intracerebral hemorrhage. Clin Neurol Neurosurg. 2015 Jun;133:1-5. doi: 10.1016/j.clineuro.2015.03.009. Epub 2015 Mar 14.
PMID: 25817570
responsible party type: Sponsor
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage
sharing ipd: No