<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/NCT03033966</url>
  </required_header>
  <id_info>
    <org_study_id>Item No.6.04, Neurosciences</org_study_id>
    <nct_id>NCT03033966</nct_id>
  </id_info>
  <brief_title>Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis</brief_title>
  <official_title>Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dhritiman Chakrabarti</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Mental Health and Neuro Sciences, India</source>
  <oversight_info>
    <has_dmc>No</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>
      Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes&#xD;
      following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage&#xD;
      literature. How the brain injury affects cerebral oxygenation in patients with CVT is not&#xD;
      currently known. Some of the factors that can affect cerebral oxygenation in patients with&#xD;
      CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in&#xD;
      Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how&#xD;
      these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the&#xD;
      cerebral oxygenation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2016</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ipsilateral Regional Cerebral Oxygen Saturation</measure>
    <time_frame>From Recruitment till 48 hours postoperative (end of study)</time_frame>
    <description>Measurement of regional cerebral oxygen saturation over ipsilateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contralateral Regional Cerebral Oxygen Saturation</measure>
    <time_frame>From Recruitment till 48 hours postoperative (end of study)</time_frame>
    <description>Measurement of regional cerebral oxygen saturation over contralateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>From Recruitment till 48 hours postoperative (end of study)</time_frame>
    <description>Measurement of systolic blood pressure before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow coma scale score</measure>
    <time_frame>From Recruitment till 48 hours postoperative (end of study)</time_frame>
    <description>Measurement of Glasgow coma scale score before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gas measurement</measure>
    <time_frame>From Recruitment till 48 hours postoperative (end of study)</time_frame>
    <description>Arterial blood gas measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin</measure>
    <time_frame>From Recruitment till 48 hours postoperative (end of study)</time_frame>
    <description>Haemoglobin measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.</description>
  </secondary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Cerebral Venous Thrombosis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIRS based Cerebral Oximetry</intervention_name>
    <description>Cerebral Oximetric measurement before and after decompressive craniectomy</description>
    <other_name>Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cerebral venous thrombosis for Decompressive craniectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on inotropic support&#xD;
&#xD;
          -  Systolic blood pressure &lt; 90 mmHg&#xD;
&#xD;
          -  Haemoglobin oxygen saturation &lt;95%&#xD;
&#xD;
          -  Refusal of consent&#xD;
&#xD;
          -  Age &lt;16 and &gt; 65 years&#xD;
&#xD;
          -  Known history of diabetes or hypertension&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any contraindication for application of cerebral oximetry sensors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NIMHANS</name>
      <address>
        <city>Bangalore City</city>
        <state>Karnataka</state>
        <zip>560029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Mental Health and Neuro Sciences, India</investigator_affiliation>
    <investigator_full_name>Dhritiman Chakrabarti</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cerebral Oximetry</keyword>
  <keyword>Cerebral Venous Thrombosis</keyword>
  <keyword>Decompressive Craniectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>May be shared on individual requests</ipd_description>
  </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/NCT03033966
org study id: Item No.6.04, Neurosciences
nct id: NCT03033966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes
      following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage
      literature. How the brain injury affects cerebral oxygenation in patients with CVT is not
      currently known. Some of the factors that can affect cerebral oxygenation in patients with
      CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in
      Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how
      these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the
      cerebral oxygenation.
observational model: Cohort
time perspective: Prospective
measure: Ipsilateral Regional Cerebral Oxygen Saturation
time frame: From Recruitment till 48 hours postoperative (end of study)
description: Measurement of regional cerebral oxygen saturation over ipsilateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
measure: Contralateral Regional Cerebral Oxygen Saturation
time frame: From Recruitment till 48 hours postoperative (end of study)
description: Measurement of regional cerebral oxygen saturation over contralateral frontal lobe before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
measure: Systolic Blood Pressure
time frame: From Recruitment till 48 hours postoperative (end of study)
description: Measurement of systolic blood pressure before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
measure: Glasgow coma scale score
time frame: From Recruitment till 48 hours postoperative (end of study)
description: Measurement of Glasgow coma scale score before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
measure: Arterial blood gas measurement
time frame: From Recruitment till 48 hours postoperative (end of study)
description: Arterial blood gas measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
measure: Haemoglobin
time frame: From Recruitment till 48 hours postoperative (end of study)
description: Haemoglobin measurement before and after decompressive craniectomy with follow up at postoperative 24 and 48 hours.
intervention type: Device
intervention name: NIRS based Cerebral Oximetry
description: Cerebral Oximetric measurement before and after decompressive craniectomy
other name: Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: National Institute of Mental Health and Neuro Sciences, India
investigator full name: Dhritiman Chakrabarti
investigator title: Assistant Professor
mesh term: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: No
ipd description: May be shared on individual requests