<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/NCT02219035</url>
  </required_header>
  <id_info>
    <org_study_id>14/0088</org_study_id>
    <nct_id>NCT02219035</nct_id>
  </id_info>
  <brief_title>A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).</brief_title>
  <official_title>A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand&#xD;
      factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13&#xD;
      levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global&#xD;
      haemostasis will be assessed using thrombin generation and the relation between increase&#xD;
      thrombin generation and VWF explored. Thrombin generation will be performed pre and post&#xD;
      filtration for the presence of procoagulant microparticles. These parameters will be&#xD;
      investigated acutely, at presentation and in convalescence; in addition, the effect on these&#xD;
      parameters of treatment such as thrombolysis may be informative. Correlation between measured&#xD;
      parameters and adverse clinical outcome would be used to identify markers of severity and&#xD;
      progression of ischaemic stroke and identification of potential novel approaches to therapy&#xD;
      that might improve outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <primary_completion_date type="Anticipated">December 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>Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>stroke-ischaemic</arm_group_label>
    <description>no interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stroke -haemorrhagic</arm_group_label>
    <description>no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stroke: not confirmed</arm_group_label>
    <description>no intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        all acute admissions presenting with ? stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt;18 years of age presenting within 9 hours of onset of symptoms will be&#xD;
             recruited from the hyperacute stroke unit at UCLH.&#xD;
&#xD;
          -  Patients in whom stroke has been excluded or in whom intracerebral haemorrhage has&#xD;
             been diagnosed are to be included as 'controls'. The definitive diagnosis will not be&#xD;
             immediately obvious at presentation.&#xD;
&#xD;
          -  Written consent will be obtained from patients or their nearest relative, particularly&#xD;
             in patients with aphasia/dysphasia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 years old&#xD;
&#xD;
          -  Patients with systemic vasculitis or active malignancy will be excluded.&#xD;
&#xD;
          -  Patients not wishing to participate&#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>Marie Scully</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Scully, PI</last_name>
    <phone>07834322302</phone>
    <email>m.scully@ucl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Debra Ellis</last_name>
    <email>debra.ellis@uclh.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UCLH</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Marie SCULLY</last_name>
      <email>m.scully@ucl.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>presentation with</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Brain Injuries</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/NCT02219035
org study id: 14/0088
nct id: NCT02219035
lead sponsor: 
has dmc: Yes
In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand
      factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13
      levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global
      haemostasis will be assessed using thrombin generation and the relation between increase
      thrombin generation and VWF explored. Thrombin generation will be performed pre and post
      filtration for the presence of procoagulant microparticles. These parameters will be
      investigated acutely, at presentation and in convalescence; in addition, the effect on these
      parameters of treatment such as thrombolysis may be informative. Correlation between measured
      parameters and adverse clinical outcome would be used to identify markers of severity and
      progression of ischaemic stroke and identification of potential novel approaches to therapy
      that might improve outcome.
observational model: Cohort
time perspective: Prospective
measure: Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity.
time frame: 2 years
arm group label: stroke-ischaemic
description: no interventions
arm group label: stroke -haemorrhagic
description: no intervention
arm group label: stroke: not confirmed
description: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Scully
role: Principal Investigator
affiliation: UCLH
last name: Marie Scully, PI
phone: 07834322302
email: m.scully@ucl.ac.uk
last name: Debra Ellis
email: debra.ellis@uclh.nhs.uk
facility: 
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stroke
mesh term: Brain Injuries