Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial
Condition: Whole Blood Donation and Leukoreduction
Intervention: Hemanext Red Blood Cell Processing System
Intervention 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Red Blood Cells

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study donor must be ≥ 18 years of age.

          -  Study donor must be ≥ 110 pounds.

          -  Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).

          -  Study donor's hemoglobin must be ≥12.5 g/dL if female and ≥13.0 g/dL if male.

          -  Study donor's hematocrit must be ≥ 38% if female and ≥39% if male.Study participants
             must meet EITHER hemoglobin or hematocrit criteria.

          -  Study donor must meet all criteria per respective site's Research Blood Donation
             Record (BDR).

          -  Study donor's most recent single RBC unit donation must have been ≥56 days prior to
             study donation.

          -  Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to
             study donation.

          -  Study donor must have consented to study participation by reviewing and having
             expressed understanding the site-respective IRB-approved informed consent form prior
             to undergoing any study related procedures.

             21 CFR 50

          -  Study donor's testing results from collected blood does not indicate a risk of
             transfusion-transmitted disease (TTD)*.

          -  Study donors must agree to report adverse events from the time of signing the informed
             consent to twenty-four hours following the end of their active study involvement.

          -  Female study donors must not be pregnant, expected to be pregnant or breastfeeding.

          -  Female donors who participate in the in vivo portion of the study:

        Women of child-bearing age must not be pregnant as determined by a negative pregnancy test
        prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically
        sterile women may be exempt from the pregnancy testing requirement.

        Exclusion Criteria:

          -  Study donor is < 18 years of age.

          -  Study donor < 110 pounds.

          -  Study donor's body temperature is > 37.5°C / 99.5°F (oral).

          -  Study donor's hemoglobin is < 12.5 g/dL if female and < 13.0 g/dL if male.

          -  Study donor's hematocrit is < 38% if female and < 39% if male.

          -  Study donor does not meet all criteria per respective site's Research Blood Donation
             Record (BDR).

          -  Study donor's most recent single RBC unit donation was < 56 days prior to study
             donation.

          -  Study donor's most recent double RBC unit donation was < 112 days prior to study
             donation.

          -  Study donor has not consented to study participation.

          -  Study donor's testing results from collected blood does indicate a risk of
             transfusion-transmitted disease (TTD)*.

          -  Female donors who participate in the in vivo portion of the study: study donor is
             pregnant, expected to be pregnant or breastfeeding.