<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/NCT01686659</url>
  </required_header>
  <id_info>
    <org_study_id>NACHO</org_study_id>
    <nct_id>NCT01686659</nct_id>
  </id_info>
  <brief_title>Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management</brief_title>
  <acronym>NACHO</acronym>
  <official_title>Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Society for the Advancement of Blood Management, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Society for the Advancement of Blood Management, Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center cluster-randomized trial with the following Specific Aims:&#xD;
&#xD;
        -  To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC&#xD;
           transfusions in patients undergoing surgeries associated with a significant risk of&#xD;
           bleeding.&#xD;
&#xD;
        -  To evaluate if patients monitored with continuous noninvasive hemoglobin experience less&#xD;
           frequent complications and shorter hospital stay compared with patients who are not&#xD;
           being monitored with continuous noninvasive hemoglobin.&#xD;
&#xD;
      Accordingly, the study hypotheses are defined as follows:&#xD;
&#xD;
        -  The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will&#xD;
           not reduce the RBC transfusions in patients undergoing surgeries associated with a&#xD;
           significant risk of bleeding.&#xD;
&#xD;
        -  The secondary hypothesis is that in patients monitored with continuous noninvasive&#xD;
           hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus,&#xD;
           there will be less frequent complications compared with patients who are not being&#xD;
           monitored with continuous noninvasive hemoglobin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a matched-pair cluster-randomized controlled trial. At each participating centers,&#xD;
      consenting eligible Anesthesiologists will be grouped into matched pairs based on their&#xD;
      practice characteristics and experience (namely, their main surgical service/procedures and&#xD;
      their years of experience working as a clinician responsible for making transfusion&#xD;
      decisions). From each pair, Anesthesiologists will be randomly allocated to either treat&#xD;
      their patients while having access to data from a continuous noninvasive hemoglobin&#xD;
      monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) (SpHb group) or&#xD;
      without access to SpHb/PVI data, under standard of care (control group). Regardless of&#xD;
      randomization, all patients will be monitored with the device but the data will be blinded&#xD;
      and not be available to the Anesthesiologist to be used in the management of the control&#xD;
      group. Only in the SpHb group, the SpHb/PVI data will be provided live to the&#xD;
      Anesthesiologist, to be used during management of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of Intraoperative RBC Transfusion</measure>
    <time_frame>From the first surgical incision to the wound closure</time_frame>
    <description>Number of allogeneic RBC units transfused intraoperatively per patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative RBC Transfusion Rate</measure>
    <time_frame>From the first surgical incision to the wound closure</time_frame>
    <description>Occurrence of any allogeneic RBC transfusions intraoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Perioperative RBC Transfusion</measure>
    <time_frame>From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)</time_frame>
    <description>Total number of allogeneic RBC units transfused perioperatively during hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ischemic Events</measure>
    <time_frame>From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)</time_frame>
    <description>Incidence of new (or worsening of pre-existing) ischemic events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From time of surgery to 30 days after the surgery</time_frame>
    <description>Any death occuring during surgery or within 30-day period following the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>From time of surgery to time of discharge from hospital (an estimated average of 5 days)</time_frame>
    <description>Length of post-surgery hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">470</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>SpHb Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These are the patients whose primary anesthesiologists have been allocated to treat them while having access to data from a continuous noninvasive hemoglobin monitoring device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These are the patients whose primary anesthesiologists have been allocated to treat them without having access to data from a continuous noninvasive hemoglobin monitoring device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Noninvasive Hemoglobin Monitoring</intervention_name>
    <description>Availability of data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) to the clinicians in the operating room</description>
    <arm_group_label>SpHb Arm</arm_group_label>
    <other_name>SpHb</other_name>
    <other_name>Radical-7</other_name>
    <other_name>Radical 7 Pulse CO-Oximeter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing one of the listed major surgeries associated with&#xD;
             possibility of significant blood loss&#xD;
&#xD;
          -  Consenting patients who are primarily managed by the consenting Anesthesiologists&#xD;
             participating in the study (Not applicable at participating centers which have&#xD;
             obtained a waiver of informed consent for the patients from their respective IRB)&#xD;
&#xD;
          -  At least one finger available and accessible for performing non-invasive hemoglobin&#xD;
             monitoring (preoperative perfusion index greater than 0.5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patients who do not fit the criteria for use of sensor, specifically, any patient&#xD;
             with nail polish and/or a nail deformity, or obstructed physical access (e.g. due to&#xD;
             bandage) to all fingers that would be used for sensor placement, in a manner that&#xD;
             interferes with satisfactory sensor placement&#xD;
&#xD;
          -  Any patients being monitored with motor evoked potential devices&#xD;
&#xD;
          -  Any patients with a known hemoglobinopathy&#xD;
&#xD;
          -  Any patients undergoing Cardio-Pulmonary Bypass (CPB)&#xD;
&#xD;
          -  Any patients who cannot be transfused or has refused consent for a blood transfusion&#xD;
&#xD;
          -  Patients who are moribund/salvage cases as determined by the participating&#xD;
             Anesthesiologist in charge of management of the patient in the operating room&#xD;
&#xD;
          -  Patients being treated by any artificial oxygen carriers within 30 days of hospital&#xD;
             stay&#xD;
&#xD;
          -  Patients who are actively enrolled in or within 30 days of completion of any other&#xD;
             study (except for purely observational studies with no intervention)&#xD;
&#xD;
          -  Patients being managed outside of an operating room in the participating centers, or&#xD;
             in operating room with conditions not conducive to perform and complete the study&#xD;
             procedures (including use of the hemoglobin monitoring device)&#xD;
&#xD;
          -  Patients younger than 18 years old&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Any patients expected to receive transfusion preoperatively&#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>Aryeh Shander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Englewood Hospital &amp; Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mazyar Javidroozi, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Englewood Hospital &amp; Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aryeh Shander, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Englewood Hospital &amp; Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard Melseth</last_name>
    <phone>602-343-7458</phone>
    <email>rmelseth@sabm.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mazyar Javidroozi, MD, PhD</last_name>
    <phone>201-894-3917</phone>
    <email>mazyarjr@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pedro P Tanaka, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Pedro P Tanaka, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergio Bergese, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato</city>
        <state>MI</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University School of Medicine</name>
      <address>
        <city>Chuo-ku Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>April 20, 2018</last_update_submitted>
  <last_update_submitted_qc>April 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transfusion</keyword>
  <keyword>Continuous Hemoglobin Monitoring</keyword>
  <keyword>SpHb</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chrysarobin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01686659
org study id: NACHO
nct id: NCT01686659
lead sponsor: 
has dmc: Yes
This is a multi-center cluster-randomized trial with the following Specific Aims:

        -  To evaluate if continuous noninvasive hemoglobin monitoring will reduce the RBC
           transfusions in patients undergoing surgeries associated with a significant risk of
           bleeding.

        -  To evaluate if patients monitored with continuous noninvasive hemoglobin experience less
           frequent complications and shorter hospital stay compared with patients who are not
           being monitored with continuous noninvasive hemoglobin.

      Accordingly, the study hypotheses are defined as follows:

        -  The primary null hypothesis is that continuous noninvasive hemoglobin monitoring will
           not reduce the RBC transfusions in patients undergoing surgeries associated with a
           significant risk of bleeding.

        -  The secondary hypothesis is that in patients monitored with continuous noninvasive
           hemoglobin, there will be earlier warning of critical drops in hemoglobin, and thus,
           there will be less frequent complications compared with patients who are not being
           monitored with continuous noninvasive hemoglobin.
This is a matched-pair cluster-randomized controlled trial. At each participating centers,
      consenting eligible Anesthesiologists will be grouped into matched pairs based on their
      practice characteristics and experience (namely, their main surgical service/procedures and
      their years of experience working as a clinician responsible for making transfusion
      decisions). From each pair, Anesthesiologists will be randomly allocated to either treat
      their patients while having access to data from a continuous noninvasive hemoglobin
      monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) (SpHb group) or
      without access to SpHb/PVI data, under standard of care (control group). Regardless of
      randomization, all patients will be monitored with the device but the data will be blinded
      and not be available to the Anesthesiologist to be used in the management of the control
      group. Only in the SpHb group, the SpHb/PVI data will be provided live to the
      Anesthesiologist, to be used during management of the patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Amount of Intraoperative RBC Transfusion
time frame: From the first surgical incision to the wound closure
description: Number of allogeneic RBC units transfused intraoperatively per patient
measure: Intraoperative RBC Transfusion Rate
time frame: From the first surgical incision to the wound closure
description: Occurrence of any allogeneic RBC transfusions intraoperatively
measure: Amount of Perioperative RBC Transfusion
time frame: From time of admission to the hospital to the time of discharge or death whichever sooner (an estimated average of 6 days)
description: Total number of allogeneic RBC units transfused perioperatively during hospital stay
measure: Ischemic Events
time frame: From time of surgery to the time of discharge or death whichever sooner (an estimated average of 5 days)
description: Incidence of new (or worsening of pre-existing) ischemic events
measure: Mortality
time frame: From time of surgery to 30 days after the surgery
description: Any death occuring during surgery or within 30-day period following the surgery
measure: Length of Stay
time frame: From time of surgery to time of discharge from hospital (an estimated average of 5 days)
description: Length of post-surgery hospital stay
arm group label: SpHb Arm
arm group type: Experimental
description: These are the patients whose primary anesthesiologists have been allocated to treat them while having access to data from a continuous noninvasive hemoglobin monitoring device
arm group label: Control Arm
arm group type: No Intervention
description: These are the patients whose primary anesthesiologists have been allocated to treat them without having access to data from a continuous noninvasive hemoglobin monitoring device
intervention type: Device
intervention name: Continuous Noninvasive Hemoglobin Monitoring
description: Availability of data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) to the clinicians in the operating room
arm group label: SpHb Arm
other name: SpHb
other name: Radical-7
other name: Radical 7 Pulse CO-Oximeter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aryeh Shander, MD
role: Principal Investigator
affiliation: Englewood Hospital & Medical Center
last name: Mazyar Javidroozi, MD, PhD
role: Study Director
affiliation: Englewood Hospital & Medical Center
last name: Aryeh Shander, MD
role: Study Chair
affiliation: Englewood Hospital & Medical Center
last name: Richard Melseth
phone: 602-343-7458
email: rmelseth@sabm.org
last name: Mazyar Javidroozi, MD, PhD
phone: 201-894-3917
email: mazyarjr@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
country: France
country: Italy
country: Japan
country: United States
responsible party type: Sponsor
mesh term: Chrysarobin