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/NCT06026618</url>
    </required_header>
    <id_info>
      <org_study_id>21/19</org_study_id>
      <nct_id>NCT06026618</nct_id>
    </id_info>
    <brief_title>Perioperative Management of Preoperative Anemia in Colorectal Cancer</brief_title>
    <official_title>Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Consorci Sanitari Integral</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Consorci Sanitari Integral</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>
        Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer&#xD;
        outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery&#xD;
        after surgery thus often worsening short-term results, and allogenic red blood cells&#xD;
        transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and&#xD;
        cancer-specific survival.&#xD;
  &#xD;
        Patient Blood Management (PBM) systems are an evidence-based multimodal approach focused on&#xD;
        safe and rational use of blood products, mainly through a proper PA assessment, a&#xD;
        minimization of procedural blood loos and strict transfusion policies. Given the high&#xD;
        prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse&#xD;
        events, it is expected that PBM implementation in said scenario carries a decrease in&#xD;
        complications and an improved survival rate. Available literature to date supports&#xD;
        preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers&#xD;
        exist that limit the expected implementation of PBM systems in colorectal surgery.&#xD;
  &#xD;
        The present study aims to evaluate feasibility of a PBM pathway implementation in a&#xD;
        high-volume CRC Surgery Unit based on completion of anemia screening and treatment before&#xD;
        surgery and changes of allogenic products use along the years. The objective is to estimate&#xD;
        the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA&#xD;
        measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2012</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Actual">January 31, 2019</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Hemoglobin</measure>
      <time_frame>Baseline and up to 30 days</time_frame>
      <description>Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total iron dose</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Total iron dose administered from the first visit until surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of days needed to complete treatment</measure>
      <time_frame>up to 30 days</time_frame>
      <description>days of treatment before surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of complications related to IVI administration</measure>
      <time_frame>up to 30 days</time_frame>
      <description>number of complications related to IVI administration</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">1294</enrollment>
    <condition>Anemia</condition>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>cohort 1</arm_group_label>
      <description>non-anemic patients (Hb &gt; 13 g/dL)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cohort 2</arm_group_label>
      <description>mildly anemic patients (Hb 12-13 mg/dL) without criteria for IVI therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cohort 3</arm_group_label>
      <description>patients treated with IVI (Hb &lt; 12mg/dL or Hb 12-13mg/dL with iron deficiency or risk factors for bleeding)</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with colorrectal cancer attended at the hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with Colorectal Cancer&#xD;
  &#xD;
            -  Patients with an indication of elective radical surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  treatment with red blood cells transfusion before assessment in the PBM Anemia Clinic&#xD;
  &#xD;
            -  non-iron deficient anemia&#xD;
  &#xD;
            -  treatment with Sucrose-based IVI or Oral Iron (OI) preparations not strictly&#xD;
               controlled by the PBM clinic&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Hospital de Sant Joan Despí, CSI</name>
        <address>
          <city>Sant Joan Despí</city>
          <state>Barcelona</state>
          <zip>08970</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Anemia</keyword>
    <keyword>Colorectal Cancer</keyword>
    <keyword>Intravenous Iron Therapy</keyword>
    <keyword>Transfusion</keyword>
    <keyword>Patient Blood Management</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Anemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06026618
  org study id: 21/19
  nct id: NCT06026618
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer
        outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery
        after surgery thus often worsening short-term results, and allogenic red blood cells
        transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and
        cancer-specific survival.
  
        Patient Blood Management (PBM) systems are an evidence-based multimodal approach focused on
        safe and rational use of blood products, mainly through a proper PA assessment, a
        minimization of procedural blood loos and strict transfusion policies. Given the high
        prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse
        events, it is expected that PBM implementation in said scenario carries a decrease in
        complications and an improved survival rate. Available literature to date supports
        preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers
        exist that limit the expected implementation of PBM systems in colorectal surgery.
  
        The present study aims to evaluate feasibility of a PBM pathway implementation in a
        high-volume CRC Surgery Unit based on completion of anemia screening and treatment before
        surgery and changes of allogenic products use along the years. The objective is to estimate
        the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA
        measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.
  observational model: Cohort
  time perspective: Other
  measure: Change in Hemoglobin
  time frame: Baseline and up to 30 days
  description: Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery
  measure: Total iron dose
  time frame: up to 30 days
  description: Total iron dose administered from the first visit until surgery
  measure: number of days needed to complete treatment
  time frame: up to 30 days
  description: days of treatment before surgery
  measure: number of complications related to IVI administration
  time frame: up to 30 days
  description: number of complications related to IVI administration
  arm group label: cohort 1
  description: non-anemic patients (Hb > 13 g/dL)
  arm group label: cohort 2
  description: mildly anemic patients (Hb 12-13 mg/dL) without criteria for IVI therapy
  arm group label: cohort 3
  description: patients treated with IVI (Hb < 12mg/dL or Hb 12-13mg/dL with iron deficiency or risk factors for bleeding)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Anemia