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/NCT06028854</url>
    </required_header>
    <id_info>
      <org_study_id>OAIC 1337/23</org_study_id>
      <nct_id>NCT06028854</nct_id>
    </id_info>
    <brief_title>Blood Characteristics and Abdominal Emergency Surgery</brief_title>
    <official_title>Association Between Preoperative Blood Characteristics and Mortality in Abdominal Emergency Surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Chile</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Chile</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>
        After surgical tissue damage, cellular blood components are involved in tissue repair&#xD;
        processes, yet their preoperative characteristics are not considered in routine clinical&#xD;
        practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Surgical injuries initiate the recruitment of cellular blood components for tissue repair.&#xD;
        Baseline inflammation levels and cellular response to tissue damage are absent from&#xD;
        perioperative management algorithms despite their importance in regeneration. This project&#xD;
        seeks to examine patients preoperative parameters before surgery and evaluate if there is a&#xD;
        correlation with clinical outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</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>Death</measure>
      <time_frame>1 year</time_frame>
      <description>The number of deceased patients.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Surgical Wound</condition>
    <arm_group>
      <arm_group_label>High Neutrophil count</arm_group_label>
      <description>Patients with high neutrophil count in their preoperative complete blood count</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low Neutrophil count</arm_group_label>
      <description>Patients with low neutrophil count in their preoperative complete blood count</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood cells&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with acute intrabdominal pathology who requires surgery in the next 24 hours.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a) Patients between 18 and 65 years of age at the time of surgery. b) Patients with&#xD;
               acute intra-abdominal pathology requiring emergency surgery. c) Complete blood count&#xD;
               performed in the emergency department of our center within the 24 hours prior to&#xD;
               surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  a) Patients who are users of anticoagulation prior to admission for any reason; b)&#xD;
               Patients who have had previous hospitalization or surgery in the last 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Felipe Maldonado</last_name>
      <role>Study Chair</role>
      <affiliation>Hospital Clinico de la Universidad de Chile</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Felipe Maldonado, MD MSc</last_name>
      <phone>+56 2 2978 8221</phone>
      <email>fmaldonado@uchile.cl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Clínico de la Universidad de Chile</name>
        <address>
          <city>Independencia</city>
          <state>Santiago</state>
          <zip>8380456</zip>
          <country>Chile</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Chile</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 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 8, 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>Emergencies</mesh_term>
      <mesh_term>Surgical Wound</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/NCT06028854
  org study id: OAIC 1337/23
  nct id: NCT06028854
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  After surgical tissue damage, cellular blood components are involved in tissue repair
        processes, yet their preoperative characteristics are not considered in routine clinical
        practice.
  Surgical injuries initiate the recruitment of cellular blood components for tissue repair.
        Baseline inflammation levels and cellular response to tissue damage are absent from
        perioperative management algorithms despite their importance in regeneration. This project
        seeks to examine patients preoperative parameters before surgery and evaluate if there is a
        correlation with clinical outcomes.
  observational model: Cohort
  time perspective: Prospective
  measure: Death
  time frame: 1 year
  description: The number of deceased patients.
  arm group label: High Neutrophil count
  description: Patients with high neutrophil count in their preoperative complete blood count
  arm group label: Low Neutrophil count
  description: Patients with low neutrophil count in their preoperative complete blood count
  Blood cells
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Felipe Maldonado
  role: Study Chair
  affiliation: Hospital Clinico de la Universidad de Chile
  last name: Felipe Maldonado, MD MSc
  phone: +56 2 2978 8221
  email: fmaldonado@uchile.cl
  facility: 
  country: Chile
  responsible party type: Sponsor
  mesh term: Emergencies
  mesh term: Surgical Wound
  sharing ipd: No