xml: <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/NCT06037187</url>
    </required_header>
    <id_info>
      <org_study_id>0016-23-EP</org_study_id>
      <nct_id>NCT06037187</nct_id>
    </id_info>
    <brief_title>Coagulopathy of Immunodermatologic Diseases</brief_title>
    <official_title>Coagulopathy of Immunodermatologic Diseases The Molecular, Prognostic, and Therapeutic Implications of Crosstalk Between Coagulation, Fibrinolysis, and Inflammation in Immune-Mediated Skin Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nebraska</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Nebraska</source>
    <oversight_info>
      <has_dmc>No</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>
        This study will examine the coagulation and fibrinolysis profiles of those with autoimmune&#xD;
        skin diseases. Blood samples will be collected from participants with active/poorly&#xD;
        controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin&#xD;
        diseases. A one-time sample from 15 general dermatology outpatients who do not have a known&#xD;
        or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or&#xD;
        cutaneous malignancy will also be collected to serve as control. Blood samples from both&#xD;
        participant populations will be analyzed for coagulation and inflammatory markers and&#xD;
        compared. The results of this study may help inform future studies on the utility of&#xD;
        analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to examine the coagulation and fibrinolysis profiles of those&#xD;
        with autoimmune skin diseases. This will be accomplished by collecting blood samples from&#xD;
        participants with both active/poorly controlled immune-mediated skin diseases and&#xD;
        mild/latent/well-controlled immune-mediated skin diseases. A one-time sample will be&#xD;
        collected from 15 general dermatology outpatients who do not have a known or suspected&#xD;
        diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous&#xD;
        malignancy to serve as the control population. Blood samples from both participant&#xD;
        populations will be analyzed for coagulation and inflammatory markers and compared. The&#xD;
        results of this study may help inform future studies on the utility of analyzing coagulation&#xD;
        and fibrinolysis profiles of patients with autoimmune skin diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 9, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 22, 2025</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>Thromboelastography</measure>
      <time_frame>2 years</time_frame>
      <description>Thromboelastography is a viscoelastic hemostatic assay that measures the global viscoelastic properties of whole blood clot formation under low shear stress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>tPA-challenged Thromboelastography</measure>
      <time_frame>2 years</time_frame>
      <description>Tests patients blood resistance to tPA-mediated clot lysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activated partial thromboplastin time</measure>
      <time_frame>2 years</time_frame>
      <description>Activated partial thromboplastin time measures the length of time (in seconds) that it takes for clotting to occur when specific reagents are added to plasma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International normalized ratio</measure>
      <time_frame>2 years</time_frame>
      <description>International Normalized Ratio is a measure of how long it takes your blood to clot.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Autoimmune Bullous Dermatosis</condition>
    <arm_group>
      <arm_group_label>Immune-mediated condition</arm_group_label>
      <description>Participants with an immune-mediated condition</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without immune-mediated dermatologic condition</arm_group_label>
      <description>Participants without an immune-mediated dermatologic condition</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood Draw</intervention_name>
      <description>Standard coagulation assays (aPTT, INR, ACT), viscoelastic coagulation profiles (rotational thromboelastometry (ROTEM)/thromboelastography (TEG), tPA-challenged ROTEM/TEG), and molecular profiling</description>
      <arm_group_label>Immune-mediated condition</arm_group_label>
      <arm_group_label>Without immune-mediated dermatologic condition</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients seen at University of Nebraska Medical Center diagnosed with autoimmune bullous&#xD;
          disease and patients without a autoimmune bullous disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. For the study group: diagnosis of immune-mediated skin disease including but not&#xD;
               limited to bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid,&#xD;
               cutaneous lupus erythematosus, dermatomyositis&#xD;
  &#xD;
            2. For control group: no diagnosis of immune-mediated skin&#xD;
  &#xD;
            3. For study group: receiving care from one or more of the Principal or Secondary&#xD;
               Investigators&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unfit to provide consent&#xD;
  &#xD;
            2. P2Y12 inhibitor use in the past 4 weeks&#xD;
  &#xD;
            3. History of internal malignancy prior to enrolling in the study or suspected&#xD;
               internal/systemic malignancy during time of the study (i.e. will not exclude&#xD;
               pre-malignant or local, early stage cutaneous malignancies)&#xD;
  &#xD;
            4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone&#xD;
               fracture) within 4 weeks of the study&#xD;
  &#xD;
            5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks&#xD;
  &#xD;
            6. If patient is unable to provide detailed history and if we do not have sufficient&#xD;
               history on record.&#xD;
  &#xD;
            7. Less than 19 years of age&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erin X Barrett, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Nebraska</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Megan Wackel, MS</last_name>
      <phone>402-559-3825</phone>
      <email>megan.wackel@unmc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Nebraska Medical Center</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68198</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Megan Wackel, MS</last_name>
        <phone>402-559-3825</phone>
        <email>megan.wackel@unmc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Skin Diseases</mesh_term>
      <mesh_term>Skin Diseases, Vesiculobullous</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037187
  org study id: 0016-23-EP
  nct id: NCT06037187
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will examine the coagulation and fibrinolysis profiles of those with autoimmune
        skin diseases. Blood samples will be collected from participants with active/poorly
        controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin
        diseases. A one-time sample from 15 general dermatology outpatients who do not have a known
        or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or
        cutaneous malignancy will also be collected to serve as control. Blood samples from both
        participant populations will be analyzed for coagulation and inflammatory markers and
        compared. The results of this study may help inform future studies on the utility of
        analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.
  The purpose of this study is to examine the coagulation and fibrinolysis profiles of those
        with autoimmune skin diseases. This will be accomplished by collecting blood samples from
        participants with both active/poorly controlled immune-mediated skin diseases and
        mild/latent/well-controlled immune-mediated skin diseases. A one-time sample will be
        collected from 15 general dermatology outpatients who do not have a known or suspected
        diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous
        malignancy to serve as the control population. Blood samples from both participant
        populations will be analyzed for coagulation and inflammatory markers and compared. The
        results of this study may help inform future studies on the utility of analyzing coagulation
        and fibrinolysis profiles of patients with autoimmune skin diseases.
  observational model: Cohort
  time perspective: Prospective
  measure: Thromboelastography
  time frame: 2 years
  description: Thromboelastography is a viscoelastic hemostatic assay that measures the global viscoelastic properties of whole blood clot formation under low shear stress.
  measure: tPA-challenged Thromboelastography
  time frame: 2 years
  description: Tests patients blood resistance to tPA-mediated clot lysis.
  measure: Activated partial thromboplastin time
  time frame: 2 years
  description: Activated partial thromboplastin time measures the length of time (in seconds) that it takes for clotting to occur when specific reagents are added to plasma.
  measure: International normalized ratio
  time frame: 2 years
  description: International Normalized Ratio is a measure of how long it takes your blood to clot.
  arm group label: Immune-mediated condition
  description: Participants with an immune-mediated condition
  arm group label: Without immune-mediated dermatologic condition
  description: Participants without an immune-mediated dermatologic condition
  intervention type: Diagnostic Test
  intervention name: Blood Draw
  description: Standard coagulation assays (aPTT, INR, ACT), viscoelastic coagulation profiles (rotational thromboelastometry (ROTEM)/thromboelastography (TEG), tPA-challenged ROTEM/TEG), and molecular profiling
  arm group label: Immune-mediated condition
  arm group label: Without immune-mediated dermatologic condition
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erin X Barrett, MD
  role: Principal Investigator
  affiliation: University of Nebraska
  last name: Megan Wackel, MS
  phone: 402-559-3825
  email: megan.wackel@unmc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Skin Diseases
  mesh term: Skin Diseases, Vesiculobullous
  sharing ipd: No