<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/NCT01686763</url>
  </required_header>
  <id_info>
    <org_study_id>CEI 1147</org_study_id>
    <nct_id>NCT01686763</nct_id>
  </id_info>
  <brief_title>Endothelin-1 and Methabolites Concentrations in Mycrodialysis and Cerebrospinal Fluid in Subarachnoid Hemorrhage Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <brief_summary>
    <textblock>
      Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after&#xD;
      subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of&#xD;
      ET-1 are not sensitive enough to predict the development of vasospasm representing the&#xD;
      average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a&#xD;
      technique able to detect molecule concentrations in a small perivascular area. The&#xD;
      investigators performed a prospective observational clinical study to test the hypothesis&#xD;
      that MD ET-1 concentrations should be a sensitive predictor for vasospasm.&#xD;
&#xD;
      Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale&#xD;
      admitted to the ICU were consecutively studied. All patients received surgery within 48 hours&#xD;
      from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and&#xD;
      samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels;&#xD;
      ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and&#xD;
      after 7 days two angiographies were performed to detect the degree and extent of vasospasm,&#xD;
      Transcranial Doppler and neurological evaluation were daily performed. Patients were then&#xD;
      classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV),&#xD;
      presence of vasospasm (CV), acute neurological deterioration (AND).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <primary_completion_date type="Actual">December 2008</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>cerebral vasospasm incidence</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Subarachnoid Hemorrhage, Aneurysmal</condition>
  <arm_group>
    <arm_group_label>subarachnoid hemorrhage disease</arm_group_label>
    <description>subarachnoid hemorrhage patients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale&#xD;
        admitted to the ICU were consecutively studied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosys of subarachnoid hemorrhage&#xD;
&#xD;
          -  angiographic proof of aneurysm&#xD;
&#xD;
          -  admission within 24 hours from the subarachnoid hemorrhage&#xD;
&#xD;
          -  presence of an intraventricular catheter and a microdialysis catheter placed either&#xD;
             after admission or at the time of the surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moribund&#xD;
&#xD;
          -  GCS=3&#xD;
&#xD;
          -  denied consent&#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>Luciana Mascia, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin, Italy</affiliation>
  </overall_official>
  <verification_date>December 2009</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>March 15, 2013</last_update_submitted>
  <last_update_submitted_qc>March 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Luciana Mascia</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT01686763
org study id: CEI 1147
nct id: NCT01686763
lead sponsor: 
Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after
      subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of
      ET-1 are not sensitive enough to predict the development of vasospasm representing the
      average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a
      technique able to detect molecule concentrations in a small perivascular area. The
      investigators performed a prospective observational clinical study to test the hypothesis
      that MD ET-1 concentrations should be a sensitive predictor for vasospasm.

      Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale
      admitted to the ICU were consecutively studied. All patients received surgery within 48 hours
      from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and
      samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels;
      ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and
      after 7 days two angiographies were performed to detect the degree and extent of vasospasm,
      Transcranial Doppler and neurological evaluation were daily performed. Patients were then
      classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV),
      presence of vasospasm (CV), acute neurological deterioration (AND).
observational model: Cohort
time perspective: Prospective
measure: cerebral vasospasm incidence
time frame: 14 days
arm group label: subarachnoid hemorrhage disease
description: subarachnoid hemorrhage patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luciana Mascia, MD, PhD
role: Principal Investigator
affiliation: University of Turin, Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Luciana Mascia
investigator title: MD, PhD
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage