Inactivation of Whole Blood With Mirasol
Condition: Focus of Study: Radiolabel Recovery and Survival of RBCs
Intervention: Mirasol System for Whole Blood
Intervention description: LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pathogen reduction technology

Summary:

      The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red
      blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as
      leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible whole blood donor

          -  Age ≥ 18 years, of either sex

          -  Able to commit to the study follow-up schedule

          -  Subjects must have adequate bilateral antecubital venous access for WB collection and
             follow-up blood draws

          -  Negative screening test panel for infectious diseases

          -  Subjects of child-bearing potential (female or male) must agree to use effective
             contraceptive during the course of the study per site guidelines

          -  Subjects must agree to report adverse events (AEs) during the required reporting
             period

          -  Negative direct antiglobulin test (DAT) with subject's RBC

          -  Negative indirect antiglobulin test (IAT) with subject's serum

        Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to,
        reinfusion):

          -  Maintenance of healthy status

          -  Negative direct antiglobulin test (DAT) with subject's RBC (fresh)

          -  Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus
             autologous stored LR-pRBC

          -  Negative serum or urine pregnancy test in females

        Exclusion Criteria:

          -  Any serious medical illness and/or therapy, including: abnormal bleeding episodes,
             clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled
             hypertension, heart disease, surgery with bleeding complications, epilepsy or any
             major surgery (with general or spinal anesthesia) within the last 6 months

          -  Pregnant or nursing females; For women of childbearing potential, negative serum or
             urine pregnancy tests at the time of WB donation and before the reinfusion are
             required

          -  Unable to give informed consent

          -  Participation currently, or within the last 12 months, in another investigational
             trial that would potentially interfere with the analysis of this investigation (e.g.,
             pharmaceutical)

          -  Have received an accumulated radiation dose that would exclude them from the study
             according to the local radiation safety limits established by each institution

          -  Inability to comply with the protocol in the opinion of the investigator