<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/NCT01709786</url>
  </required_header>
  <id_info>
    <org_study_id>Tsuei-2012-06</org_study_id>
    <nct_id>NCT01709786</nct_id>
  </id_info>
  <brief_title>Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage</brief_title>
  <official_title>Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Air Force</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in&#xD;
      patients with suspected hemorrhage. These methods will be compared with standard laboratory&#xD;
      measurements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anemia and bleeding are major causes of morbidity and mortality in both surgical and&#xD;
      nonsurgical patients. The current standard of care for monitoring patients at risk for&#xD;
      bleeding is serial measurement of hemoglobin levels. At present, the photometric&#xD;
      cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the&#xD;
      lab, and is currently the gold standard. However, this method has potential for delay before&#xD;
      final results are obtained.&#xD;
&#xD;
      Immediate hemoglobin measurements are available with portable point-of-care devices such as&#xD;
      the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute.&#xD;
      Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level,&#xD;
      and as such may not be as accurate in detecting blood loss when compared with the gold&#xD;
      standard of laboratory analysis.&#xD;
&#xD;
      Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed.&#xD;
      This novel technology measures the differential optical density of wavelengths of light&#xD;
      passed through the finger in a method similar to conventional pulse oximetry. While some&#xD;
      studies have reported that this device appears to be accurate in patients undergoing elective&#xD;
      surgical procedures, more recent work suggests that this accuracy degrades with increased&#xD;
      blood loss, lower oximeter signal quality and lower absolute Hgb values.&#xD;
&#xD;
      We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility&#xD;
      of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of&#xD;
      rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use&#xD;
      of this technology may result in earlier detection of ongoing hemorrhage, expedite&#xD;
      appropriate treatment, and improve patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement</measure>
    <time_frame>n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.</time_frame>
    <description>Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.&#xD;
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement</measure>
    <time_frame>n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.</time_frame>
    <description>When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.&#xD;
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Patients with Suspected Hemorrhage</arm_group_label>
    <description>There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the Surgical Intensive Care Unit of University Hospital, Cincinnati&#xD;
        will be eligible for this study if they are at risk of ongoing bleeding and require serial&#xD;
        CBC measurements. A patient will not be eligible if he or she is:(1) less than 18 years of&#xD;
        age, (2) a prisoner, or if (3) clinicians are unable to take pulse oximetry readings due to&#xD;
        injuries, burns, amputations, or related problems.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admitted to surgical intensive care unit (SICU), and&#xD;
&#xD;
          -  at risk of ongoing bleeding, and&#xD;
&#xD;
          -  requires serial CBC measurements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age, or&#xD;
&#xD;
          -  a prisoner, or&#xD;
&#xD;
          -  unable to have pulse oximetry readings (due to injuries, burns, amputations, or&#xD;
             related problems)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>van KAMPEN E, ZIJLSTRA WG. Standardization of hemoglobinometry. II. The hemiglobincyanide method. Clin Chim Acta. 1961 Jul;6:538-44. doi: 10.1016/0009-8981(61)90145-0. No abstract available.</citation>
    <PMID>14453500</PMID>
  </reference>
  <reference>
    <citation>International committee for standardization in haematology. Recommendations for haemoglobinometry in human blood. Br J Haematol. 1967 Apr;13:71-5. doi: 10.1111/j.1365-2141.1967.tb00751.x. No abstract available.</citation>
    <PMID>5608692</PMID>
  </reference>
  <reference>
    <citation>Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.</citation>
    <PMID>22238693</PMID>
  </reference>
  <reference>
    <citation>May JM. Vitamin C transport and its role in the central nervous system. Subcell Biochem. 2012;56:85-103. doi: 10.1007/978-94-007-2199-9_6.</citation>
    <PMID>22116696</PMID>
  </reference>
  <reference>
    <citation>Butwick AJ, Hilton G, Riley ET, Carvalho B. Non-invasive measurement of hemoglobin during cesarean hysterectomy: a case series. Int J Obstet Anesth. 2011 Jul;20(3):240-5. doi: 10.1016/j.ijoa.2011.03.009. Epub 2011 Jun 2.</citation>
    <PMID>21640577</PMID>
  </reference>
  <reference>
    <citation>Hahn RG, Li Y, Zdolsek J. Non-invasive monitoring of blood haemoglobin for analysis of fluid volume kinetics. Acta Anaesthesiol Scand. 2010 Nov;54(10):1233-40. doi: 10.1111/j.1399-6576.2010.02321.x.</citation>
    <PMID>21039345</PMID>
  </reference>
  <reference>
    <citation>Myers D, McGraw M, George M, Mulier K, Beilman G. Tissue hemoglobin index: a non-invasive optical measure of total tissue hemoglobin. Crit Care. 2009;13 Suppl 5(Suppl 5):S2. doi: 10.1186/cc8000. Epub 2009 Nov 30.</citation>
    <PMID>19951386</PMID>
  </reference>
  <reference>
    <citation>Santora RJ, Moore FA. Monitoring trauma and intensive care unit resuscitation with tissue hemoglobin oxygen saturation. Crit Care. 2009;13 Suppl 5(Suppl 5):S10. doi: 10.1186/cc8008. Epub 2009 Nov 30.</citation>
    <PMID>19951382</PMID>
  </reference>
  <reference>
    <citation>Lamhaut L, Apriotesei R, Combes X, Lejay M, Carli P, Vivien B. Comparison of the accuracy of noninvasive hemoglobin monitoring by spectrophotometry (SpHb) and HemoCue(R) with automated laboratory hemoglobin measurement. Anesthesiology. 2011 Sep;115(3):548-54. doi: 10.1097/ALN.0b013e3182270c22.</citation>
    <PMID>21716091</PMID>
  </reference>
  <reference>
    <citation>Applegate RL 2nd, Barr SJ, Collier CE, Rook JL, Mangus DB, Allard MW. Evaluation of pulse cooximetry in patients undergoing abdominal or pelvic surgery. Anesthesiology. 2012 Jan;116(1):65-72. doi: 10.1097/ALN.0b013e31823d774f.</citation>
    <PMID>22133758</PMID>
  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>December 14, 2015</results_first_submitted>
  <results_first_submitted_qc>June 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 9, 2016</results_first_posted>
  <last_update_submitted>June 27, 2016</last_update_submitted>
  <last_update_submitted_qc>June 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Betty Tsuei</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Hemorrhage</keyword>
  <keyword>Hemoglobin</keyword>
  <keyword>Non-invasive monitoring</keyword>
  <keyword>Medical device accuracy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patients With Suspected Hemorrhage</title>
          <description>There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Adult patients (&gt;18 years of age) with the potential for hemorrhage and who were admitted to the Surgical Intensive Care Unit of a tertiary referral, Level I verified trauma center.</population>
      <group_list>
        <group group_id="B1">
          <title>Patients With Suspected Hemorrhage</title>
          <description>There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement</title>
        <description>Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.&#xD;
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.</description>
        <time_frame>n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radical-7 Hemoglobin</title>
            <description>Radical-7 hemoglobin measurement</description>
          </group>
          <group group_id="O2">
            <title>CBC Hemoglobin</title>
            <description>CBC hemoglobin measurement</description>
          </group>
        </group_list>
        <measure>
          <title>CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement</title>
          <description>Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.&#xD;
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.</description>
          <units>grams per deciliter</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="10.6" upper_limit="10.9"/>
                    <measurement group_id="O2" value="9.2" lower_limit="9.0" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Bland-Altman Analysis</param_type>
            <param_value>1.49</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement</title>
        <description>When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.&#xD;
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.</description>
        <time_frame>n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>iSTAT Hemoglobin</title>
            <description>iSTAT hemoglobin measurement</description>
          </group>
          <group group_id="O2">
            <title>CBC Hemoglobin</title>
            <description>CBC hemoglobin measurement</description>
          </group>
        </group_list>
        <measure>
          <title>CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement</title>
          <description>When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.&#xD;
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.</description>
          <units>grams per deciliter</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="8.4" upper_limit="8.7"/>
                    <measurement group_id="O2" value="9.2" lower_limit="9.0" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Limits of agreement</param_type>
            <param_value>-0.63</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During patient's hospital stay</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Radical-7 vs. CBC</title>
          <description>All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Betty Tsuei, MD</name_or_title>
      <organization>University of Cincinnati</organization>
      <phone>513-558-5661</phone>
      <email>Betty.Tsuei@uc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01709786
org study id: Tsuei-2012-06
nct id: NCT01709786
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in
      patients with suspected hemorrhage. These methods will be compared with standard laboratory
      measurements.
Anemia and bleeding are major causes of morbidity and mortality in both surgical and
      nonsurgical patients. The current standard of care for monitoring patients at risk for
      bleeding is serial measurement of hemoglobin levels. At present, the photometric
      cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the
      lab, and is currently the gold standard. However, this method has potential for delay before
      final results are obtained.

      Immediate hemoglobin measurements are available with portable point-of-care devices such as
      the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute.
      Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level,
      and as such may not be as accurate in detecting blood loss when compared with the gold
      standard of laboratory analysis.

      Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed.
      This novel technology measures the differential optical density of wavelengths of light
      passed through the finger in a method similar to conventional pulse oximetry. While some
      studies have reported that this device appears to be accurate in patients undergoing elective
      surgical procedures, more recent work suggests that this accuracy degrades with increased
      blood loss, lower oximeter signal quality and lower absolute Hgb values.

      We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility
      of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of
      rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use
      of this technology may result in earlier detection of ongoing hemorrhage, expedite
      appropriate treatment, and improve patient outcomes.
observational model: Cohort
time perspective: Prospective
measure: CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement
time frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.
description: Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.
measure: CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement
time frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.
description: When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.
arm group label: Patients with Suspected Hemorrhage
description: There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Betty Tsuei
investigator title: Professor of Surgery
mesh term: Hemorrhage
sharing ipd: No
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
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