<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/NCT04418934</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN-0004</org_study_id>
    <nct_id>NCT04418934</nct_id>
  </id_info>
  <brief_title>Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells</brief_title>
  <official_title>Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion&#xD;
      therapy through novel storage methods potentially improving their quality across the storage&#xD;
      cycle. Based on our review of the pertinent literature, there is substantial evidence&#xD;
      suggesting that prolonged exposure to oxygen during storage results in oxidative damage to&#xD;
      the red blood cells (RBC) over the course of storage leading to decreased therapeutic&#xD;
      potential. Therefore, removal of oxygen from red blood cell products prior to storage has&#xD;
      potential to preserve the cells in a more physiologically relevant state and improve the&#xD;
      clinical outcomes of patients that receive blood transfusions in a variety of therapeutic&#xD;
      realms1.&#xD;
&#xD;
      Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag&#xD;
      system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard&#xD;
      processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in&#xD;
      AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB)&#xD;
      processing bag which allows for the rapid diffusion of oxygen out of the blood, through a&#xD;
      sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing,&#xD;
      the blood is transferred again from the ORB into the Hemanext Storage Bag (HSB) which will&#xD;
      preserve the hypoxic state of the LR-RBC product for the duration of cold storage.&#xD;
&#xD;
      The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The&#xD;
      pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients&#xD;
      at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH&#xD;
      grants and contracts that can substantially mitigate the damage done to the blood supply by&#xD;
      this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the&#xD;
      effects of future crises. Limited shelf life is a key component in exacerbating the current&#xD;
      blood supply crisis. Successful completion of this project will allow earliest possible&#xD;
      availability (within 9-12 months) of the high quality Hemanext RBC with significantly&#xD;
      extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC&#xD;
      showed a reduction of &gt;50% of blood volume required for resuscitation from hemorrhage in a&#xD;
      pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to&#xD;
      improve still further the efficacy of Hemanext blood and further to reduce the transfusion&#xD;
      volume needed to achieve treatment objectives. In addition, extending the shelf life of the&#xD;
      Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of&#xD;
      major blood shortages due to reduced donor activity during threats to blood security such a&#xD;
      COVID-19 pandemics and other crises.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Grant application for study was rejected&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</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>Day 56 of storage</time_frame>
    <description>Percentage of packed Red Blood Cell units with hemolysis at day 56 of storage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells</measure>
    <time_frame>Day 56 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">0</enrollment>
  <condition>Whole Blood Donations 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 One device.</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 One</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 56 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. Study donor must be ≥ 110 pounds. Study donor's body&#xD;
        temperature must be ≤ 37.5°C / 99.5°F (oral). Study donor's hemoglobin must be ≥12.5 g/dL&#xD;
        if female and ≥13.0 g/dL if male. Study donor's hematocrit must be ≥ 38% if female and ≥39%&#xD;
        if male.Study participants must meet EITHER hemoglobin or hematocrit criteria.&#xD;
&#xD;
        Study donor must meet all criteria per respective site's Research Blood Donation Record&#xD;
        (BDR).&#xD;
&#xD;
        Study donor's most recent single RBC unit donation must have been ≥56 days prior to study&#xD;
        donation.&#xD;
&#xD;
        Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study&#xD;
        donation.&#xD;
&#xD;
        Study donor must have consented to study participation by reviewing and having expressed&#xD;
        understanding the site-respective IRB-approved informed consent form prior to undergoing&#xD;
        any study related procedures.&#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. Study donor &lt; 110 pounds. Study donor's body temperature&#xD;
        is &gt; 37.5°C / 99.5°F (oral). Study donor's hemoglobin is &lt; 12.5 g/dL if female and &lt; 13.0&#xD;
        g/dL if male. Study donor's hematocrit is &lt; 38% if female and &lt; 39% if male. Study donor&#xD;
        does not meet all criteria per respective site's Research Blood Donation Record (BDR).&#xD;
&#xD;
        Study donor's most recent single RBC unit donation was &lt; 56 days prior to study donation.&#xD;
&#xD;
        Study donor's most recent double RBC unit donation was &lt; 112 days prior to study donation.&#xD;
&#xD;
        Study donor has not consented to study participation. Study donor's testing results from&#xD;
        collected blood does indicate a risk of transfusion-transmitted disease (TTD)*.&#xD;
&#xD;
        Female donors who participate in the in vivo portion of the study: study donor is pregnant,&#xD;
        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>Jose Cancelas, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hoxworth Blood Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philip Howard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Red Cross Mid-Atlantic Research Facility</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>23510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418934
org study id: CLIN-0004
nct id: NCT04418934
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion
      therapy through novel storage methods potentially improving their quality across the storage
      cycle. 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 (RBC) over the course of storage 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 and improve the
      clinical outcomes of patients that receive blood transfusions in a variety of therapeutic
      realms1.

      Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag
      system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard
      processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in
      AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB)
      processing bag 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 hypoxic state of the LR-RBC product for the duration of cold storage.

      The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The
      pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients
      at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH
      grants and contracts that can substantially mitigate the damage done to the blood supply by
      this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the
      effects of future crises. Limited shelf life is a key component in exacerbating the current
      blood supply crisis. Successful completion of this project will allow earliest possible
      availability (within 9-12 months) of the high quality Hemanext RBC with significantly
      extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC
      showed a reduction of >50% of blood volume required for resuscitation from hemorrhage in a
      pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to
      improve still further the efficacy of Hemanext blood and further to reduce the transfusion
      volume needed to achieve treatment objectives. In addition, extending the shelf life of the
      Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of
      major blood shortages due to reduced donor activity during threats to blood security such a
      COVID-19 pandemics and other crises.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: % of Red Blood Cells With Hemolysis
time frame: Day 56 of storage
description: Percentage of packed Red Blood Cell units with hemolysis at day 56 of storage.
measure: Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells
time frame: Day 56 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 One device.
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 One
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 56 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: Jose Cancelas, MD, PhD
role: Principal Investigator
affiliation: Hoxworth Blood Center
last name: Philip Howard, MD
role: Principal Investigator
affiliation: American Red Cross Mid-Atlantic Research Facility
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No