<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/NCT04484233</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 00010254-2020-131</org_study_id>
    <nct_id>NCT04484233</nct_id>
  </id_info>
  <brief_title>Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care</brief_title>
  <acronym>iAnemia</acronym>
  <official_title>Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care: Feasibility &amp; Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intelligence Anesthesia</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intelligence Anesthesia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anemia need to be diagnosed and treated, following several guidelines. However, the&#xD;
      complexity of these recommendations leads to low compliance and to unnecessary and harmful&#xD;
      per- and postoperative blood transfusion.&#xD;
&#xD;
      In order to improve practices and regarding the complexity of the guidelines, the latest&#xD;
      European Consensus Conference recommends the use of decision support systems for the&#xD;
      management of preoperative anemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization defines anemia as a hemoglobin level of less than 13 g/dL in&#xD;
      adult men and less than 12 g/dL in women.&#xD;
&#xD;
      The cause of these anemias is most often deficient with 17% iron deficiency. This deficiency&#xD;
      is related to age, inflammatory diseases, blood loss, and absorption disorders mainly. Anemia&#xD;
      must be diagnosed preoperatively and treated.&#xD;
&#xD;
      To reduce transfusion in the perioperative period there are various possibilities: increase&#xD;
      of the preoperative erythrocyte mass, reduction of losses, use of the blood that has been&#xD;
      applied.&#xD;
&#xD;
      The impact of these preoperative strategies can be considerable. In their work, Beattie and&#xD;
      al demonstrates that transfusion is associated with an increase in mortality at 90 days,&#xD;
      proportional to the volume transfused, with certainly a higher risk in fragile subjects. More&#xD;
      recently, an American registry of more than 220,000 patients showed that 30% had preoperative&#xD;
      anemia. This anemia not only significantly increased mortality, but all causes of comorbidity&#xD;
      were aggravated in an anemic patient.&#xD;
&#xD;
      However, the complexity of these recommendations leads to low compliance and to unnecessary&#xD;
      and harmful per- and postoperative blood transfusion.&#xD;
&#xD;
      In order to improve practices and regarding the complexity of the guidelines, the latest&#xD;
      European Consensus Conference recommends the use of decision support systems for the&#xD;
      management of preoperative anemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average global score obtained for the two groups.</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>The mean number of correct answers (out of possible 10);</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average subcategories score obtained for the two groups.</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>The mean number of correct answers (out of possible 10);</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Decision Support Systems</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical Decision Support Group</arm_group_label>
    <description>Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management helped by dedicated clinical decision support systems for patient blood management (iAnemia, Intelligence Anesthesia).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iAnemia Decision Support System</intervention_name>
    <description>iAnemia permits to display the appropriate guideline using several inputs about a patient: age, type and delay of the surgery, gender, hemoglobin level, and iron deficiency status.</description>
    <arm_group_label>Clinical Decision Support Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anesthesiologist:&#xD;
&#xD;
          -  Less than one year experience in anesthesia&#xD;
&#xD;
          -  2 to 5 years of experience&#xD;
&#xD;
          -  5 to 10 years of experience&#xD;
&#xD;
          -  10 to 20 years of experience&#xD;
&#xD;
          -  More than 20 years of experience&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unfinished questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yassine Moussali, MD</last_name>
    <phone>+33620858135</phone>
    <email>y.moussali@intelligenceanesthesia.com</email>
  </overall_contact>
  <reference>
    <citation>Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.</citation>
    <PMID>30860564</PMID>
  </reference>
  <reference>
    <citation>Rothschild JM, McGurk S, Honour M, Lu L, McClendon AA, Srivastava P, Churchill WH, Kaufman RM, Avorn J, Cook EF, Bates DW. Assessment of education and computerized decision support interventions for improving transfusion practice. Transfusion. 2007 Feb;47(2):228-39. doi: 10.1111/j.1537-2995.2007.01093.x.</citation>
    <PMID>17302768</PMID>
  </reference>
  <reference>
    <citation>Adams ES, Longhurst CA, Pageler N, Widen E, Franzon D, Cornfield DN. Computerized physician order entry with decision support decreases blood transfusions in children. Pediatrics. 2011 May;127(5):e1112-9. doi: 10.1542/peds.2010-3252. Epub 2011 Apr 18.</citation>
    <PMID>21502229</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clinical Decision Support Systems</keyword>
  <keyword>Patient Blood Management</keyword>
  <keyword>Preoperative Anemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</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/NCT04484233
org study id: IRB 00010254-2020-131
nct id: NCT04484233
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Anemia need to be diagnosed and treated, following several guidelines. However, the
      complexity of these recommendations leads to low compliance and to unnecessary and harmful
      per- and postoperative blood transfusion.

      In order to improve practices and regarding the complexity of the guidelines, the latest
      European Consensus Conference recommends the use of decision support systems for the
      management of preoperative anemia.
The World Health Organization defines anemia as a hemoglobin level of less than 13 g/dL in
      adult men and less than 12 g/dL in women.

      The cause of these anemias is most often deficient with 17% iron deficiency. This deficiency
      is related to age, inflammatory diseases, blood loss, and absorption disorders mainly. Anemia
      must be diagnosed preoperatively and treated.

      To reduce transfusion in the perioperative period there are various possibilities: increase
      of the preoperative erythrocyte mass, reduction of losses, use of the blood that has been
      applied.

      The impact of these preoperative strategies can be considerable. In their work, Beattie and
      al demonstrates that transfusion is associated with an increase in mortality at 90 days,
      proportional to the volume transfused, with certainly a higher risk in fragile subjects. More
      recently, an American registry of more than 220,000 patients showed that 30% had preoperative
      anemia. This anemia not only significantly increased mortality, but all causes of comorbidity
      were aggravated in an anemic patient.

      However, the complexity of these recommendations leads to low compliance and to unnecessary
      and harmful per- and postoperative blood transfusion.

      In order to improve practices and regarding the complexity of the guidelines, the latest
      European Consensus Conference recommends the use of decision support systems for the
      management of preoperative anemia.
observational model: Case-Control
time perspective: Prospective
measure: Average global score obtained for the two groups.
time frame: Up to 24 weeks
description: The mean number of correct answers (out of possible 10);
measure: Average subcategories score obtained for the two groups.
time frame: Up to 24 weeks
description: The mean number of correct answers (out of possible 10);
arm group label: Control Group
description: Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management.
arm group label: Clinical Decision Support Group
description: Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management helped by dedicated clinical decision support systems for patient blood management (iAnemia, Intelligence Anesthesia).
intervention type: Device
intervention name: iAnemia Decision Support System
description: iAnemia permits to display the appropriate guideline using several inputs about a patient: age, type and delay of the surgery, gender, hemoglobin level, and iron deficiency status.
arm group label: Clinical Decision Support Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yassine Moussali, MD
phone: +33620858135
email: y.moussali@intelligenceanesthesia.com
citation: Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.
PMID: 30860564
citation: Rothschild JM, McGurk S, Honour M, Lu L, McClendon AA, Srivastava P, Churchill WH, Kaufman RM, Avorn J, Cook EF, Bates DW. Assessment of education and computerized decision support interventions for improving transfusion practice. Transfusion. 2007 Feb;47(2):228-39. doi: 10.1111/j.1537-2995.2007.01093.x.
PMID: 17302768
citation: Adams ES, Longhurst CA, Pageler N, Widen E, Franzon D, Cornfield DN. Computerized physician order entry with decision support decreases blood transfusions in children. Pediatrics. 2011 May;127(5):e1112-9. doi: 10.1542/peds.2010-3252. Epub 2011 Apr 18.
PMID: 21502229
responsible party type: Sponsor
mesh term: Anemia
sharing ipd: Undecided