<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/NCT03286465</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-17-0280</org_study_id>
    <nct_id>NCT03286465</nct_id>
  </id_info>
  <brief_title>Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions</brief_title>
  <official_title>Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes&#xD;
      reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients&#xD;
      compared with the use of adult size tubes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order</measure>
    <time_frame>from time of admission to intensive care unit (ICU) to 30 days after admission to ICU</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)</measure>
    <time_frame>from time of randomization to completion of study (up to 30 days after ICU admission)</time_frame>
    <description>This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU</measure>
    <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis</measure>
    <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
    <description>An inadequate blood sample is defined as any blood sample that requires recollection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Mortality</measure>
    <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Phlebotomy Volume</measure>
    <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
    <description>The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Pediatric phlebotomy tubes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of pediatric size tubes for diagnostic blood collection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult phlebotomy tubes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of adult size tubes for diagnostic blood collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pediatric phlebotomy tubes</intervention_name>
    <description>Use of pediatric size tubes for diagnostic blood collection.</description>
    <arm_group_label>Pediatric phlebotomy tubes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adult phlebotomy tubes</intervention_name>
    <description>Use of adult size tubes for diagnostic blood collection.</description>
    <arm_group_label>Adult phlebotomy tubes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston&#xD;
&#xD;
          -  ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will&#xD;
             be the most recent hemoglobin value available at the time of screening for inclusion&#xD;
             in the study.&#xD;
&#xD;
          -  Randomization is expected within 12 hour of admission to the ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the&#xD;
             frequency of hemoglobin monitoring or to an order for a medication, transfusion,&#xD;
             procedure, or consultation intended to prevent or treat bleeding.&#xD;
&#xD;
          -  Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis,&#xD;
             autoimmune hemolytic anemia)&#xD;
&#xD;
          -  Bone marrow disorder (e.g. aplastic anemia, marrow infiltration disorder, chemotherapy&#xD;
             within the last 8 weeks)&#xD;
&#xD;
          -  Jehovah's Witnesses&#xD;
&#xD;
          -  Patient is comfort care measures only&#xD;
&#xD;
          -  Refractory shock: mean arterial blood pressure below 60 mmHg despite maximal doses of&#xD;
             3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70&#xD;
             mcg/min; vasopressin 0.04 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min;&#xD;
             phenylephrine 350 mcg/min&#xD;
&#xD;
          -  Severe acidosis: potential of hydrogen (pH) below 7 in more than one arterial blood&#xD;
             gas within 24 hours of ICU admission in the absence of diabetic ketoacidosis Surgical&#xD;
             admission diagnosis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current prisoner&#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>Javier Barreda Garcia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>September 22, 2019</results_first_submitted>
  <results_first_submitted_qc>August 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2021</results_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Javier Barreda Garcia</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>blood transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03286465/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pediatric Phlebotomy Tubes</title>
          <description>Use of pediatric size tubes for diagnostic blood collection.</description>
        </group>
        <group group_id="P2">
          <title>Adult Phlebotomy Tubes</title>
          <description>Use of adult size tubes for diagnostic blood collection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pediatric Phlebotomy Tubes</title>
          <description>Use of pediatric size tubes for diagnostic blood collection.</description>
        </group>
        <group group_id="B2">
          <title>Adult Phlebotomy Tubes</title>
          <description>Use of adult size tubes for diagnostic blood collection.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" spread="16.7"/>
                    <measurement group_id="B2" value="57" spread="18.5"/>
                    <measurement group_id="B3" value="56.2" spread="17.9"/>
                  </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="45"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin concentration at intensive care unit (ICU) admission</title>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.4" spread="2.4"/>
                    <measurement group_id="B2" value="11.1" spread="2.3"/>
                    <measurement group_id="B3" value="11.24" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from ICU admission to randomization</title>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.3" lower_limit="1.5" upper_limit="8"/>
                    <measurement group_id="B2" value="5.7" lower_limit="2.6" upper_limit="8.6"/>
                    <measurement group_id="B3" value="5.64" lower_limit="2.15" upper_limit="8.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated blood volume</title>
          <units>liters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.9" lower_limit="4.2" upper_limit="5.6"/>
                    <measurement group_id="B2" value="4.6" lower_limit="3.9" upper_limit="5.4"/>
                    <measurement group_id="B3" value="4.77" lower_limit="3.97" upper_limit="5.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants with chronic hemodialysis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants with chronic kidney disease but no dialysis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants with active malignancy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants with recent history of anemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Charlson comorbidity index</title>
          <description>The Charlson comorbidity index predicts 10-year survival in patients with multiple comorbidities. Total score rantes from 0 to 33. The higher the score, the higher the chance of mortality.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="B2" value="4.0" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="B3" value="3" lower_limit="2" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ICU Admission Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute Cardiovascular Disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute renal failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolic disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-infectious inflammatory disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants who had invasive mechanical ventilation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>APACHE II score</title>
          <description>The APACHE II score estimates ICU mortality. Total score ranges from 0 to 71 points, with higher scores indicating greater mortality.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.0" lower_limit="14" upper_limit="29"/>
                    <measurement group_id="B2" value="23.0" lower_limit="16" upper_limit="28"/>
                    <measurement group_id="B3" value="22" lower_limit="15.75" upper_limit="28.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order</title>
        <time_frame>from time of admission to intensive care unit (ICU) to 30 days after admission to ICU</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Phlebotomy Tubes</title>
            <description>Use of pediatric size tubes for diagnostic blood collection.</description>
          </group>
          <group group_id="O2">
            <title>Adult Phlebotomy Tubes</title>
            <description>Use of adult size tubes for diagnostic blood collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)</title>
        <description>This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).</description>
        <time_frame>from time of randomization to completion of study (up to 30 days after ICU admission)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Phlebotomy Tubes</title>
            <description>Use of pediatric size tubes for diagnostic blood collection.</description>
          </group>
          <group group_id="O2">
            <title>Adult Phlebotomy Tubes</title>
            <description>Use of adult size tubes for diagnostic blood collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)</title>
          <description>This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).</description>
          <units>g/dL/day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" lower_limit="-0.48" upper_limit="0.021"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-0.54" upper_limit="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU</title>
        <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Phlebotomy Tubes</title>
            <description>Use of pediatric size tubes for diagnostic blood collection.</description>
          </group>
          <group group_id="O2">
            <title>Adult Phlebotomy Tubes</title>
            <description>Use of adult size tubes for diagnostic blood collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis</title>
        <description>An inadequate blood sample is defined as any blood sample that requires recollection.</description>
        <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
        <population>This outcome data was not collected in the arm using adult phlebotomy tubes.</population>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Phlebotomy Tubes</title>
            <description>Use of pediatric size tubes for diagnostic blood collection.</description>
          </group>
          <group group_id="O2">
            <title>Adult Phlebotomy Tubes</title>
            <description>Use of adult size tubes for diagnostic blood collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis</title>
          <description>An inadequate blood sample is defined as any blood sample that requires recollection.</description>
          <population>This outcome data was not collected in the arm using adult phlebotomy tubes.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ICU Mortality</title>
        <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Phlebotomy Tubes</title>
            <description>Use of pediatric size tubes for diagnostic blood collection.</description>
          </group>
          <group group_id="O2">
            <title>Adult Phlebotomy Tubes</title>
            <description>Use of adult size tubes for diagnostic blood collection.</description>
          </group>
        </group_list>
        <measure>
          <title>ICU Mortality</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Phlebotomy Volume</title>
        <description>The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.</description>
        <time_frame>completion of study (up to 30 days after ICU admission)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Phlebotomy Tubes</title>
            <description>Use of pediatric size tubes for diagnostic blood collection.</description>
          </group>
          <group group_id="O2">
            <title>Adult Phlebotomy Tubes</title>
            <description>Use of adult size tubes for diagnostic blood collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Phlebotomy Volume</title>
          <description>The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.</description>
          <units>mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="7" upper_limit="38"/>
                    <measurement group_id="O2" value="50" lower_limit="27" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>time of randomization to completion of study (up to 30 days after ICU admission)</time_frame>
      <desc>Systematically assessed for RBC transfusion-related adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pediatric Phlebotomy Tubes</title>
          <description>Use of pediatric size tubes for diagnostic blood collection.</description>
        </group>
        <group group_id="E2">
          <title>Adult Phlebotomy Tubes</title>
          <description>Use of adult size tubes for diagnostic blood collection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>death</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Javier Barreda Garcia, MD</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>713-500-6838</phone>
      <email>Javier.BarredaGarcia@uth.tmc.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/NCT03286465
org study id: HSC-MS-17-0280
nct id: NCT03286465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes
      reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients
      compared with the use of adult size tubes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
time frame: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
measure: Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
time frame: from time of randomization to completion of study (up to 30 days after ICU admission)
description: This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).
measure: Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
time frame: completion of study (up to 30 days after ICU admission)
measure: Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
time frame: completion of study (up to 30 days after ICU admission)
description: An inadequate blood sample is defined as any blood sample that requires recollection.
measure: ICU Mortality
time frame: completion of study (up to 30 days after ICU admission)
measure: Total Phlebotomy Volume
time frame: completion of study (up to 30 days after ICU admission)
description: The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.
arm group label: Pediatric phlebotomy tubes
arm group type: Experimental
description: Use of pediatric size tubes for diagnostic blood collection.
arm group label: Adult phlebotomy tubes
arm group type: Active Comparator
description: Use of adult size tubes for diagnostic blood collection.
intervention type: Device
intervention name: Pediatric phlebotomy tubes
description: Use of pediatric size tubes for diagnostic blood collection.
arm group label: Pediatric phlebotomy tubes
intervention type: Device
intervention name: Adult phlebotomy tubes
description: Use of adult size tubes for diagnostic blood collection.
arm group label: Adult phlebotomy tubes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Barreda Garcia, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Javier Barreda Garcia
investigator title: Assistant Professor
mesh term: Critical Illness
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 