Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood
Condition: Blood Safety
Study type: Interventional

Summary: 
      A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit
      will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then
      stored for 24h. At the end of storage, platelet concentrates will be separated from the unit,
      tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the
      donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets
      will be separated from this fresh sample and labeled with another radio-isotope. Then, the
      two radiolabeled platelet aliquots will be infused simultaneously and the recovery and
      survival of the two types of platelets will be measured.
    

Detailed description: 
      The study will be a prospective, single-center, single-arm, intra-subject controlled,
      open-label design.

      Subjects will donate one unit of fresh whole blood. This unit will be treated with the
      Mirasol PRT System for whole blood and then stored for 24 hours ± 1 hour at 22 ± 2°C. At the
      end of storage, platelet concentrates will be separated from the unit according to the
      Biomedical Excellence for Safer Transfusion (BEST) procedures. An aliquot will be removed
      from the platelet concentrates for testing and for radiolabeling and reinfusion. The
      platelets in Mirasol-treated whole blood will be tested for key in vitro parameters directly
      after treatment (Day 0) and at the end of storage (Day 1). Sterility testing will also be
      conducted on the stored units.

      An aliquot of the platelet concentrate separated from each unit of stored Mirasol-treated
      whole blood will be radiolabeled with either 111Indium Oxine or 51Chromium, and autologously
      infused. An intra-subject control will be utilized as per the BEST guidelines for platelet
      radiolabeling procedures. On the day of infusion, the subject will donate a fresh sample of
      whole blood. Platelets will be separated from this fresh sample and labeled with the
      radio-isotope that was not used to label the subject's Mirasol-treated platelet sample. The
      two radiolabeled platelet aliquots (Mirasol-treated and fresh control) will be infused
      simultaneously, and the recovery and survival of the two types of platelets will be measured
      according to standard institutional practice.
    

Intervention name(s): Mirasol treatment of whole blood
Intervention type(s): Device
Intervention description(s): Subject will be infused with two products at the same time:
radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol.
radio-labeled platelets derived from subject's untreated fresh whole blood.
Other intervention name(s): Mirasol pathogen reduction system; Mirasol system for whole blood
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: pathogen reduction technology; whole blood; Platelets; Mirasol