Clinical trial NCT02330081: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood
Official title: Mirasol System for Whole Blood: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Safety
Keywords: pathogen reduction technology
whole blood
Platelets
Mirasol
Lead sponsor: Terumo BCTbio
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2015-01-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Platelet 24-hour Relative Recovery
timeFrame: 24 hours
measure: Relative Platelet Survival
timeFrame: Days 1 through 10 post-infusion
Secondary outcomes:
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
measure: in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin
timeFrame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Terumo BCT VP Science, Clinical and Laboratory
name: Ray Goodrich, PhD
role: STUDY_CHAIR
References: