<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/NCT03301779</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN-0001</org_study_id>
    <nct_id>NCT03301779</nct_id>
  </id_info>
  <brief_title>Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial</brief_title>
  <official_title>Clinical Investigation to Evaluate the New Health Sciences Hemanext® Oxygen Reduction System for Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hemanext</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hemanext</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of Hemanext. is to improve red cell storage through novel storage methods.&#xD;
      Based on our review of the pertinent literature, there is substantial evidence suggesting&#xD;
      that prolonged exposure to oxygen during storage results in oxidative damage to the red blood&#xD;
      cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood&#xD;
      cell products prior to storage has potential to preserve the cells in a more physiologically&#xD;
      relevant state.&#xD;
&#xD;
      Currently, Hemanext has focused on the design and development of a dual compartment bag&#xD;
      system designated as the Hemanext Red Blood Cell Processing System. After standard processing&#xD;
      of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the&#xD;
      appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag&#xD;
      (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile,&#xD;
      oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood&#xD;
      is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the&#xD;
      anaerobic state of the LR-RBC product for the duration of cold storage.&#xD;
&#xD;
      Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic&#xD;
      storage on overall blood health in various storage solutions. The research team has focused&#xD;
      primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the&#xD;
      duration of storage, as well as ATP and 2,3-DPG levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In vitro and in vivo performance of O2/CO2 reduced red blood cells produced with the Hemanext&#xD;
      System will be used to demonstrate the acceptability the final product for clearance. To&#xD;
      accomplish this, the study will require a total of 100 studyevaluable donors. completing the&#xD;
      study. The study entails a randomized, paired, 2-x-2 crossover design where every study donor&#xD;
      (n = 10093) evaluable study donors who completes the study will donate a total of two whole&#xD;
      blood units with individual units being donated at least 56 days (8 weeks) apart. One unit&#xD;
      will be used as the test and the other unit will be used for the control. The order in which&#xD;
      the IP and the CP will be used to collect, filter and store the whole blood and appropriate&#xD;
      blood products (within the context of the crossover design) will be randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">March 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 6, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of Red Blood Cells With Hemolysis</measure>
    <time_frame>On day 42 of storage</time_frame>
    <description>Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells</measure>
    <time_frame>Day 42 of storage</time_frame>
    <description>The mean 24-hour, post-transfusion, in vivo red blood cell recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>% Red Blood Cells Recovered Post-Filtration</measure>
    <time_frame>Post-Filtration on Day 0</time_frame>
    <description>Percentage of red blood cells recovered after the filtration process.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Whole Blood Donation and Leukoreduction</condition>
  <arm_group>
    <arm_group_label>Investigational Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood product from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Product</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Blood product from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemanext Red Blood Cell Processing System</intervention_name>
    <description>Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.</description>
    <arm_group_label>Investigational Product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study donor must be ≥ 18 years of age.&#xD;
&#xD;
          -  Study donor must be ≥ 110 pounds.&#xD;
&#xD;
          -  Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).&#xD;
&#xD;
          -  Study donor's hemoglobin must be ≥12.5 g/dL if female and ≥13.0 g/dL if male.&#xD;
&#xD;
          -  Study donor's hematocrit must be ≥ 38% if female and ≥39% if male.Study participants&#xD;
             must meet EITHER hemoglobin or hematocrit criteria.&#xD;
&#xD;
          -  Study donor must meet all criteria per respective site's Research Blood Donation&#xD;
             Record (BDR).&#xD;
&#xD;
          -  Study donor's most recent single RBC unit donation must have been ≥56 days prior to&#xD;
             study donation.&#xD;
&#xD;
          -  Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to&#xD;
             study donation.&#xD;
&#xD;
          -  Study donor must have consented to study participation by reviewing and having&#xD;
             expressed understanding the site-respective IRB-approved informed consent form prior&#xD;
             to undergoing any study related procedures.&#xD;
&#xD;
             21 CFR 50&#xD;
&#xD;
          -  Study donor's testing results from collected blood does not indicate a risk of&#xD;
             transfusion-transmitted disease (TTD)*.&#xD;
&#xD;
          -  Study donors must agree to report adverse events from the time of signing the informed&#xD;
             consent to twenty-four hours following the end of their active study involvement.&#xD;
&#xD;
          -  Female study donors must not be pregnant, expected to be pregnant or breastfeeding.&#xD;
&#xD;
          -  Female donors who participate in the in vivo portion of the study:&#xD;
&#xD;
        Women of child-bearing age must not be pregnant as determined by a negative pregnancy test&#xD;
        prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically&#xD;
        sterile women may be exempt from the pregnancy testing requirement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study donor is &lt; 18 years of age.&#xD;
&#xD;
          -  Study donor &lt; 110 pounds.&#xD;
&#xD;
          -  Study donor's body temperature is &gt; 37.5°C / 99.5°F (oral).&#xD;
&#xD;
          -  Study donor's hemoglobin is &lt; 12.5 g/dL if female and &lt; 13.0 g/dL if male.&#xD;
&#xD;
          -  Study donor's hematocrit is &lt; 38% if female and &lt; 39% if male.&#xD;
&#xD;
          -  Study donor does not meet all criteria per respective site's Research Blood Donation&#xD;
             Record (BDR).&#xD;
&#xD;
          -  Study donor's most recent single RBC unit donation was &lt; 56 days prior to study&#xD;
             donation.&#xD;
&#xD;
          -  Study donor's most recent double RBC unit donation was &lt; 112 days prior to study&#xD;
             donation.&#xD;
&#xD;
          -  Study donor has not consented to study participation.&#xD;
&#xD;
          -  Study donor's testing results from collected blood does indicate a risk of&#xD;
             transfusion-transmitted disease (TTD)*.&#xD;
&#xD;
          -  Female donors who participate in the in vivo portion of the study: study donor is&#xD;
             pregnant, expected to be pregnant or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faye West, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Red Cross Mid-Atlantic Research Facility</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose A Cancelas Perez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hoxworth Blood Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Karafin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Versiti</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hoxworth Blood Center, University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Red Cross Mid-Atlantic Research Facility</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blood Center of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>August 13, 2019</results_first_submitted>
  <results_first_submitted_qc>March 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2020</results_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Red Blood Cells</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>November 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03301779/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were immediately assigned to a group upon enrollment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Investigational Product First, Then Control Product</title>
          <description>A donor randomized to this arm donated their first whole blood unit to be stored with the Investigational Product.These units were processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.&#xD;
These donors then donated their second whole blood unit to be stored with the Control Product. These units were stored in a Haemonetics Leukotrap Whole Blood System for 42 days at 1-6°C.</description>
        </group>
        <group group_id="P2">
          <title>Control Product First, Then Investigational Product</title>
          <description>A donor randomized to this arm donated their first whole blood unit to be stored with the Control Product. These units were stored in a Haemonetics Leukotrap Whole Blood System for 42 days at 1-6°C.&#xD;
These donors then donated their second whole blood unit to be stored with the Investigational Product.These units were processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Donors</title>
          <description>This study was a crossover design and all Donors donated units to both the Investigation and Control arms so the Baseline Measures for all donors are combined here irrespective of their randomization.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </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="47.0" spread="15.0"/>
                  </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="47"/>
                  </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>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>% of Red Blood Cells With Hemolysis</title>
        <description>Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.</description>
        <time_frame>On day 42 of storage</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational Product</title>
            <description>Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System.&#xD;
Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.</description>
          </group>
          <group group_id="O2">
            <title>Control Product</title>
            <description>Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.</description>
          </group>
        </group_list>
        <measure>
          <title>% of Red Blood Cells With Hemolysis</title>
          <description>Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.</description>
          <units>% of Red Blood Cells with Hemolysis</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.168"/>
                    <measurement group_id="O2" value="0.29" spread="0.152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells</title>
        <description>The mean 24-hour, post-transfusion, in vivo red blood cell recovery.</description>
        <time_frame>Day 42 of storage</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational Product</title>
            <description>Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System.&#xD;
Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.</description>
          </group>
          <group group_id="O2">
            <title>Control Product</title>
            <description>Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.</description>
          </group>
        </group_list>
        <measure>
          <title>Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells</title>
          <description>The mean 24-hour, post-transfusion, in vivo red blood cell recovery.</description>
          <units>% Recovery of Red Blood Cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3" spread="5.81"/>
                    <measurement group_id="O2" value="85.8" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>% Red Blood Cells Recovered Post-Filtration</title>
        <description>Percentage of red blood cells recovered after the filtration process.</description>
        <time_frame>Post-Filtration on Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational Product</title>
            <description>Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System.&#xD;
Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.</description>
          </group>
          <group group_id="O2">
            <title>Control Product</title>
            <description>Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.</description>
          </group>
        </group_list>
        <measure>
          <title>% Red Blood Cells Recovered Post-Filtration</title>
          <description>Percentage of red blood cells recovered after the filtration process.</description>
          <units>% of Red Blood Cells Recovered</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" spread="1.9"/>
                    <measurement group_id="O2" value="91.1" spread="4.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Investigational Product</title>
          <description>Blood products from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System.&#xD;
Hemanext Red Blood Cell Processing System: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.</description>
        </group>
        <group group_id="E2">
          <title>Control Product</title>
          <description>Blood products from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.</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="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicits</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Ablation</sub_title>
                <description>Participant had the procedure during their participation in the study so it was recorded as an adverse event.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Side Pain</sub_title>
                <description>This adverse event caused the participant to go see their primary care physician and lead to the discovery that they had appendicitis (recorded in the serious adverse event section)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Subject called to say he had dizziness at work after donation.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dizzyness after donation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Light-headedness after donation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bruising or pain on arm at blood donation site</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Nausea after donation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </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>
    <limitations_and_caveats>Disclaimer: The 51-Cr/99-Tc(m) labeling for 14 study subjects occurred without prior RDRC approval and was done at a site that did not meet GMP standards.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>William Iselin</name_or_title>
      <organization>Hemanext</organization>
      <phone>7813017446</phone>
      <email>william.iselin@hemanext.com</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/NCT03301779
org study id: CLIN-0001
nct id: NCT03301779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The primary goal of Hemanext. is to improve red cell storage through novel storage methods.
      Based on our review of the pertinent literature, there is substantial evidence suggesting
      that prolonged exposure to oxygen during storage results in oxidative damage to the red blood
      cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood
      cell products prior to storage has potential to preserve the cells in a more physiologically
      relevant state.

      Currently, Hemanext has focused on the design and development of a dual compartment bag
      system designated as the Hemanext Red Blood Cell Processing System. After standard processing
      of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the
      appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag
      (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile,
      oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood
      is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the
      anaerobic state of the LR-RBC product for the duration of cold storage.

      Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic
      storage on overall blood health in various storage solutions. The research team has focused
      primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the
      duration of storage, as well as ATP and 2,3-DPG levels.
In vitro and in vivo performance of O2/CO2 reduced red blood cells produced with the Hemanext
      System will be used to demonstrate the acceptability the final product for clearance. To
      accomplish this, the study will require a total of 100 studyevaluable donors. completing the
      study. The study entails a randomized, paired, 2-x-2 crossover design where every study donor
      (n = 10093) evaluable study donors who completes the study will donate a total of two whole
      blood units with individual units being donated at least 56 days (8 weeks) apart. One unit
      will be used as the test and the other unit will be used for the control. The order in which
      the IP and the CP will be used to collect, filter and store the whole blood and appropriate
      blood products (within the context of the crossover design) will be randomized.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: % of Red Blood Cells With Hemolysis
time frame: On day 42 of storage
description: Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.
measure: Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells
time frame: Day 42 of storage
description: The mean 24-hour, post-transfusion, in vivo red blood cell recovery.
measure: % Red Blood Cells Recovered Post-Filtration
time frame: Post-Filtration on Day 0
description: Percentage of red blood cells recovered after the filtration process.
arm group label: Investigational Product
arm group type: Experimental
description: Blood product from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System
arm group label: Control Product
arm group type: No Intervention
description: Blood product from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.
intervention type: Device
intervention name: Hemanext Red Blood Cell Processing System
description: Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.
arm group label: Investigational Product
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Faye West, MD
role: Principal Investigator
affiliation: American Red Cross Mid-Atlantic Research Facility
last name: Jose A Cancelas Perez, MD, PhD
role: Principal Investigator
affiliation: Hoxworth Blood Center
last name: Matthew Karafin, MD
role: Principal Investigator
affiliation: Versiti
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Disclaimer: The 51-Cr/99-Tc(m) labeling for 14 study subjects occurred without prior RDRC approval and was done at a site that did not meet GMP standards.
point of contact: 