Blood Safety
Conditions
Keywords
pathogen reduction technology, whole blood, Platelets, Mirasol
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.
Interventions
DEVICEMirasol treatment of whole blood
Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subject's untreated fresh whole blood.
Sponsors
United States Department of Defense
Terumo BCTbio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet 24-hour Relative Recovery | 24 hours | 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. |
| Relative Platelet Survival | Days 1 through 10 post-infusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 0 post-collection, day 0 post-illumination, day 1 post-storage | 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 |
| 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 - 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 - 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 | Day 0 post-collection, day 0 post-illumination, day 1 post-storage | 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. |
| 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 | — |
| 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 - Hematocrit | Day 0 post-collection, day 0 post-illumination, day 1 post-storage | — |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirasol Subject will be infused with two products at the same time:
1. radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol.
2. radio-labeled platelets derived from subjects untreated fresh whole blood.
Mirasol treatment of whole blood: Subject will be infused with two products at the same time:
1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol.
2. radio-labeled platelets derived from subject's untreated fresh whole blood. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Donation did not meet criteria | 1 |
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Mirasol |
|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 11.94 |
| Blood type A | 6 participants |
| Blood type AB | 0 participants |
| Blood type B | 1 participants |
| Blood type O | 7 participants |
| Height | 172.6 cm STANDARD_DEVIATION 9.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment Norway | 14 participants |
| Rhesus status Negative | 0 participants |
| Rhesus status Positive | 14 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
| Weight | 78.7 kg STANDARD_DEVIATION 13.68 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
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.
Time frame: 24 hours
Population: Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | Platelet 24-hour Relative Recovery | 43.31 Percentage of platelet count |
| Control Platelets | Platelet 24-hour Relative Recovery | 52.01 Percentage of platelet count |
Primary
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.
Time frame: Days 1 through 10 post-infusion
Population: Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | Relative Platelet Survival | 152.9 hours |
| Control Platelets | Relative Platelet Survival | 188.8 hours |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2 | Day 0 post-collection | 9.96 kPa | Standard Deviation 1.335 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2 | Day 0 post-illumination | 8.78 kPa | Standard Deviation 0.946 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2 | Day 1 post-storage | 13.05 kPa | Standard Deviation 1.216 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose | Day 0 post-collection | 20.50 mmol/L | Standard Deviation 1.778 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose | Day 0 post-illumination | 18.79 mmol/L | Standard Deviation 1.498 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose | Day 1 post-storage | 15.12 mmol/L | Standard Deviation 1.625 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit | Day 0 post-collection | 35.88 Percentage of total blood volume | Standard Deviation 1.945 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit | Day 0 post-illumination | 33.37 Percentage of total blood volume | Standard Deviation 1.754 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit | Day 1 post-storage | 34.49 Percentage of total blood volume | Standard Deviation 1.691 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin | Day 0 post-collection | 12.49 g/dL | Standard Deviation 0.762 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin | Day 0 post-illumination | 11.69 g/dL | Standard Deviation 0.741 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin | Day 1 post-storage | 11.73 g/dL | Standard Deviation 0.732 |
Secondary
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.
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis | Day 0 post-collection | 0.1 percentage of free hemoglobin | Standard Deviation 0.11 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis | Day 0 post-illumination | 0.1 percentage of free hemoglobin | Standard Deviation 0.1 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis | Day 1 post-storage | 0.2 percentage of free hemoglobin | Standard Deviation 0.1 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate | Day 0 post-collection | 2.01 mmol/L | Standard Deviation 0.635 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate | Day 0 post-illumination | 2.44 mmol/L | Standard Deviation 0.549 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate | Day 1 post-storage | 8.97 mmol/L | Standard Deviation 0.811 |
Secondary
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
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH | Day 0 post-collection | 7.017 units on a scale | Standard Deviation 0.0261 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH | Day 0 post-illumination | 7.027 units on a scale | Standard Deviation 0.022 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH | Day 1 post-storage | 6.804 units on a scale | Standard Deviation 0.0256 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin | Day 0 post-collection | 0.24 g/L | Standard Deviation 0.241 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin | Day 0 post-illumination | 0.22 g/L | Standard Deviation 0.204 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin | Day 1 post-storage | 0.30 g/L | Standard Deviation 0.211 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets | Day 0 post-collection | 151.77 cells * 10e9/L | Standard Deviation 43.051 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets | Day 0 post-illumination | 110.52 cells * 10e9/L | Standard Deviation 26.686 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets | Day 1 post-storage | 154.43 cells * 10e9/L | Standard Deviation 34.807 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2 | Day 0 post-collection | 5.93 kPa | Standard Deviation 1.521 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2 | Day 0 post-illumination | 6.20 kPa | Standard Deviation 2.069 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2 | Day 1 post-storage | 4.68 kPa | Standard Deviation 1.146 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium | Day 0 post-illumination | 3.10 mmol/L | Standard Deviation 0.141 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium | Day 1 post-storage | 5.86 mmol/L | Standard Deviation 0.401 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium | Day 0 post-collection | 3.11 mmol/L | Standard Deviation 0.192 |
Secondary
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
Population: Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells | Day 0 post-collection | 4.49 cells * 10e9/L | Standard Deviation 1.002 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells | Day 0 post-illumination | 4.17 cells * 10e9/L | Standard Deviation 0.98 |
| Test Platelets From Mirasol-treated Whole Blood | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells | Day 1 post-storage | 3.64 cells * 10e9/L | Standard Deviation 0.804 |