Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood (Medic)

Mirasol System for Whole Blood: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Blood Safety
• Intervention / Treatment: Device: Mirasol treatment of whole blood

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 2021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult subjects, who meet the inclusion criteria defined by the Blood Center for whole blood donation.
2. Age ≥ 18 and < 70 years
3. Able to commit to the study follow-up schedule.
4. Subjects must have adequate antecubital venous access for whole blood collection and follow-up blood draws.
5. Subjects of child-bearing potential (female or male) must agree to use effective contraception per site guideline or abstain from heterosexual intercourse during the course of the study.
6. Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets.
7. Subjects must agree to report adverse events (AEs) during the required reporting period.

Exclusion Criteria:

1. Use of medications that interfere with platelet function within 48 hours of planned whole blood collection.
2. 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).
3. Inability to comply with the protocol in the opinion of the investigator.
4. Unable or unwilling to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirasol; Subject will be infused with two products at the same time: radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol.; radio-labeled platelets derived from subjects untreated fresh whole blood.	Device: Mirasol treatment of whole blood; 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 Names: Mirasol pathogen reduction system; Mirasol system for whole blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet 24-hour Relative Recovery	Relative recovery of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC, measured as a percentage of platelets derived from freshly collected WB from the same participant. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.	24 hours
Relative Platelet Survival	Mean survival time of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC as compared to the mean survival time of fresh platelets from the same donor, measured in hours. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.	Days 1 through 10 post-infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH	pH is a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14	Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate		Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis	Hemolysis is the rupture or destruction of red blood cells (RBCs), which releases hemoglobin from inside the RBCs into the plasma (where it is called "free hemoglobin"). Hemolysis is measured as the percentage of free hemoglobin compared to the total hemoglobin in a blood sample.	Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin		Day 0 post-collection, day 0 post-illumination, day 1 post-storage

Collaborators and Investigators

• Sponsor: Terumo BCTbio
• Collaborators: United States Department of Defense
• Investigators: Study Chair: Ray Goodrich, PhD, Terumo BCT VP Science, Clinical and Laboratory

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: December 31, 2014
• First Posted (Estimate): January 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Platelets; whole blood; pathogen reduction technology; Mirasol
• Other Study ID Numbers: CTS-0081