<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/NCT04416594</url>
  </required_header>
  <id_info>
    <org_study_id>FXIII</org_study_id>
    <nct_id>NCT04416594</nct_id>
  </id_info>
  <brief_title>Impact of Acquired FXIII Deficiency on Morbidity and Mortality</brief_title>
  <official_title>Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Patricia Duque González</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational prospective study aiming to assess acquired FXIII deficiency implications in&#xD;
      morbidity and mortality&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients admitted to a large tertiary hospital with FXIII levels below 70% during their&#xD;
      hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity&#xD;
      and mortality is registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2019</start_date>
  <completion_date type="Actual">May 18, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>Cut-Point levels of FXIII</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators aim to find a laboratory parameter, a cut-point plasma level of FXIII, to identify an increased in morbidity and mortality in a mixed cohort of hospitalized patients</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Acquired Factor XIII Deficiency Disease</condition>
  <arm_group>
    <arm_group_label>Factor XIII deficiency</arm_group_label>
    <description>Patients admitted to hospital with FXIII levels below 70% during their hospital stay</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Only data collection</description>
    <arm_group_label>Factor XIII deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Medical and surgical hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FXIII levels &lt; 70%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gregorio Marañon Hospital</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Patricia Duque González</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Factor XIII</keyword>
  <keyword>Blood transfusion</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Factor XIII Deficiency</mesh_term>
    <mesh_term>Deficiency Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04416594
org study id: FXIII
nct id: NCT04416594
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observational prospective study aiming to assess acquired FXIII deficiency implications in
      morbidity and mortality
All patients admitted to a large tertiary hospital with FXIII levels below 70% during their
      hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity
      and mortality is registered.
observational model: Cohort
time perspective: Prospective
measure: Cut-Point levels of FXIII
time frame: 2 years
description: The investigators aim to find a laboratory parameter, a cut-point plasma level of FXIII, to identify an increased in morbidity and mortality in a mixed cohort of hospitalized patients
arm group label: Factor XIII deficiency
description: Patients admitted to hospital with FXIII levels below 70% during their hospital stay
intervention type: Other
intervention name: Data collection
description: Only data collection
arm group label: Factor XIII deficiency
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Patricia Duque González
investigator title: Principal Investigator
mesh term: Factor XIII Deficiency
mesh term: Deficiency Diseases
sharing ipd: Undecided