Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
Condition: Blood Donors
Intervention: SOLX (Investigational); AS-3 (Control)
Intervention description: SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.; AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Leukoreduction; Red Blood Cell post-leukoreduction recovery; Packed red blood cell post storage hemolysis; Red blood cell recovery; Plasma clotting factors; 2,3-DPG rejuvenation

Summary:

      This study will evaluate a new blood collection and filtration system that is intended to be
      used to collect, filter, separate and store red blood cells and, separately, plasma. The new
      blood collection and filtration system will be compared to an already-approved and currently
      used system. Further, this study will evaluate new processing conditions relative to the
      individual components of the collection and filtration system. All study participants will
      donate two units of whole blood with individual units being donated at least 56 days apart.
      One unit of whole blood will be donated with the new system, and the other unit will be
      collected with the already-approved system. A subset of the donors (approximately 24 of the
      120 participants) will have a small quantity of their red blood cells injected back into
      their body 42-days after they were donated in order to evaluate how well the red blood cells
      survive. Blood and blood products from all donors will be analyzed the day of collection and
      after storage (plasma after at least 30 days of storage and red blood cells after exactly 42
      days of storage).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age - Study donor must be ≥ 18 years of age

          -  Weight - Study donor must be ≥ 110 pounds

          -  Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral)

          -  Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL

          -  Hematocrit - Study donor's hematocrit must be ≥ 38%. Donor Eligibility - Study donor
             must meet all criteria per respective site's Research Blood Donation Record (BDR)

          -  Prior Donation - 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

          -  Informed Consent - 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

          -  Blood-borne Pathogens - Study donor's testing results from collected blood does not
             indicate a risk of transfusion-transmitted disease (TTD)

          -  Adverse Events - 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

          -  Pregnancy - Female study donors must not be pregnant, expected to be pregnant or
             breastfeeding. Only 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:

        -Failure to meet one or more of the above criteria