<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/NCT03261583</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3051_CARMATS</org_study_id>
    <nct_id>NCT03261583</nct_id>
  </id_info>
  <brief_title>Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery</brief_title>
  <acronym>CARMATS</acronym>
  <official_title>Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood transfusion is expensive, and has medical and safety consequences for patients who&#xD;
      benefit from it. In cardiac surgery, the data concerning the level of perioperative&#xD;
      transfusion are very heterogeneous from one center to another. In a large US cohort study of&#xD;
      798 cardiac surgery centers and 102,470 patients undergoing coronary artery bypass surgery,&#xD;
      the rate of blood transfusion varies from 8 to 93% depending on the center. It would appear&#xD;
      that the largest and most experienced centers have a blood transfusion rate of around 60%.&#xD;
&#xD;
      In addition to its beneficial role in reducing mortality induced by deep or poorly tolerated&#xD;
      anemia, current data from the literature also raise morbidity and mortality related to blood&#xD;
      transfusion. Murphy et al. Have shown, in an English cohort of cardiac surgery, that&#xD;
      transfusion of CGR was correlated with the occurrence of postoperative infections and&#xD;
      ischemic events, as well as early and late excess mortality. These effects appear as early as&#xD;
      the first transfused red blood cell, which is confirmed by a prospective Brazilian study with&#xD;
      a hazard ratio of death occurrence of 1.2 for each RBC transfused after cardiac surgery.&#xD;
&#xD;
      Preoperative anemia is found in 25% of patients in programmed cardiac surgery and its&#xD;
      etiologies are varied. Iron deficiency appears to be at the forefront, especially in coronary&#xD;
      patients for whom studies report up to 48% iron deficiency anemia. It may also be vitamin B12&#xD;
      deficiency or folate, chronic pathologies such as renal insufficiency, or any other common&#xD;
      cause of anemia.&#xD;
&#xD;
      According to the latest European recommendations, iron deficiency should be defined as &lt;100&#xD;
      ng / mL ferritin or &lt;300 ng / mL ferritin combined with a transferrin saturation &lt;20%.&#xD;
&#xD;
      In cardiac surgery, iron deficiency affects 37% of preoperative patients and is associated&#xD;
      with more frequent preoperative and postoperative anemia. It is an independent risk factor&#xD;
      for postoperative blood transfusion, even in the absence of preoperatively associated anemia&#xD;
      It is currently recommended to seek iron deficiency preoperatively during the discovery of&#xD;
      any microcytic anemia and to achieve iron substitution if found. And also to seek&#xD;
      supplemental iron deficiency in all patients with cardiac insufficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</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>Incidence of patients with iron deficiency</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">444</enrollment>
  <condition>Thoracic Surgery</condition>
  <arm_group>
    <arm_group_label>Thoracic Surgery</arm_group_label>
    <description>Observational study. It is only a matter of collecting clinical data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thoracis Surgery - Common care</intervention_name>
    <description>Observational study. It is only a matter of collecting clinical data.</description>
    <arm_group_label>Thoracic Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients programmed for cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All adult patients programmed for cardiac surgery in the cardiothoracic surgery departments&#xD;
        of Rennes, Poitiers, and Brest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children &lt;18 years;&#xD;
&#xD;
          -  Procedures for endovascular surgery;&#xD;
&#xD;
          -  Vascular surgery other than ascending aorta and lacrosse;&#xD;
&#xD;
          -  Non-cardiac thoracic surgery;&#xD;
&#xD;
          -  Persons of full age who are subject to legal protection (safeguard of justice,&#xD;
             curatorship, guardianship), persons deprived of their liberty.&#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>Baptiste Gaudriot</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brest University Hospital</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03261583
org study id: 35RC16_3051_CARMATS
nct id: NCT03261583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study.
Blood transfusion is expensive, and has medical and safety consequences for patients who
      benefit from it. In cardiac surgery, the data concerning the level of perioperative
      transfusion are very heterogeneous from one center to another. In a large US cohort study of
      798 cardiac surgery centers and 102,470 patients undergoing coronary artery bypass surgery,
      the rate of blood transfusion varies from 8 to 93% depending on the center. It would appear
      that the largest and most experienced centers have a blood transfusion rate of around 60%.

      In addition to its beneficial role in reducing mortality induced by deep or poorly tolerated
      anemia, current data from the literature also raise morbidity and mortality related to blood
      transfusion. Murphy et al. Have shown, in an English cohort of cardiac surgery, that
      transfusion of CGR was correlated with the occurrence of postoperative infections and
      ischemic events, as well as early and late excess mortality. These effects appear as early as
      the first transfused red blood cell, which is confirmed by a prospective Brazilian study with
      a hazard ratio of death occurrence of 1.2 for each RBC transfused after cardiac surgery.

      Preoperative anemia is found in 25% of patients in programmed cardiac surgery and its
      etiologies are varied. Iron deficiency appears to be at the forefront, especially in coronary
      patients for whom studies report up to 48% iron deficiency anemia. It may also be vitamin B12
      deficiency or folate, chronic pathologies such as renal insufficiency, or any other common
      cause of anemia.

      According to the latest European recommendations, iron deficiency should be defined as <100
      ng / mL ferritin or <300 ng / mL ferritin combined with a transferrin saturation <20%.

      In cardiac surgery, iron deficiency affects 37% of preoperative patients and is associated
      with more frequent preoperative and postoperative anemia. It is an independent risk factor
      for postoperative blood transfusion, even in the absence of preoperatively associated anemia
      It is currently recommended to seek iron deficiency preoperatively during the discovery of
      any microcytic anemia and to achieve iron substitution if found. And also to seek
      supplemental iron deficiency in all patients with cardiac insufficiency.
observational model: Cohort
time perspective: Prospective
measure: Incidence of patients with iron deficiency
time frame: Baseline
arm group label: Thoracic Surgery
description: Observational study. It is only a matter of collecting clinical data.
intervention type: Other
intervention name: Thoracis Surgery - Common care
description: Observational study. It is only a matter of collecting clinical data.
arm group label: Thoracic Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Baptiste Gaudriot
role: Principal Investigator
affiliation: CHU Rennes
facility: 
facility: 
country: France
responsible party type: Sponsor