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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirasol | Experimental | Subject will be infused with two products at the same time:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirasol treatment of whole blood | Device | Subject will be infused with two products at the same time:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ray Goodrich, PhD | Terumo BCT VP Science, Clinical and Laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 2021 | Norway |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirasol | Subject will be infused with two products at the same time:
Mirasol treatment of whole blood: Subject will be infused with two products at the same time:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Modified Intent to Treat population (mITT) = all enrolled subjects who signed 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). Additionally, subjects V01 and V08 exited the study prior to reinfusion of their radiolabeled platelets.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirasol | Subject will be infused with two products at the same time:
Mirasol treatment of whole blood: Subject will be infused with two products at the same time:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percentage of platelet count | 24 hours |
|
10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirasol | Subject will be infused with two products at the same time:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Crump | Terumo BCT | +1 303 231-4606 | beth.crump@terumobct.com |
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|
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Blood type | Number | participants |
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| Rhesus status | Number | participants |
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| Test Platelets From Mirasol-treated Whole Blood |
Mirasol-treated platelets: Platelets were collected from 1 Test unit of whole blood that had been treated with the Mirasol pathogen reduction process and stored for 24 hours. |
| OG001 | Control Platelets | Control platelets: An aliquot of platelets derived from a freshly collected whole blood sample |
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|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | hours | Days 1 through 10 post-infusion |
|
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|
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| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin | 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). | Posted | Mean | Standard Deviation | g/dL | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit | 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). | Posted | Mean | Standard Deviation | Percentage of total blood volume | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells | 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). | Posted | Mean | Standard Deviation | cells * 10e9/L | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets | 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). | Posted | Mean | Standard Deviation | cells * 10e9/L | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2 | 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). | Posted | Mean | Standard Deviation | kPa | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2 | 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). | Posted | Mean | Standard Deviation | kPa | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium | 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). | Posted | Mean | Standard Deviation | mmol/L | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
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| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose | 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). | Posted | Mean | Standard Deviation | mmol/L | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
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|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate | 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). | Posted | Mean | Standard Deviation | mmol/L | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
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| 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. | 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). | Posted | Mean | Standard Deviation | percentage of free hemoglobin | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
|
|
|
| Secondary | in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin | 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). | Posted | Mean | Standard Deviation | g/L | Day 0 post-collection, day 0 post-illumination, day 1 post-storage |
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| 0 |
| 22 |
| 10 |
| 22 |
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Cold/influenza | Infections and infestations | Systematic Assessment |
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| Collapsed vein during donation | Vascular disorders | Systematic Assessment |
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| Vasovagal syncope | Nervous system disorders | Systematic Assessment |
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| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blisters on both feet | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
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