Focus of Study: Radiolabel Recovery and Survival of RBCs
Conditions
Keywords
Pathogen reduction technology
Brief summary
The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects
Detailed description
This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1
Interventions
DEVICEMirasol System for Whole Blood
LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.
Sponsors
U.S. Army Medical Research and Development Command
Terumo BCTbio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eligible whole blood donor * Age ≥ 18 years, of either sex * Able to commit to the study follow-up schedule * Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws * Negative screening test panel for infectious diseases * Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines * Subjects must agree to report adverse events (AEs) during the required reporting period * Negative direct antiglobulin test (DAT) with subject's RBC * Negative indirect antiglobulin test (IAT) with subject's serum Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion): * Maintenance of healthy status * Negative direct antiglobulin test (DAT) with subject's RBC (fresh) * Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC * Negative serum or urine pregnancy test in females
Exclusion criteria
* Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months * Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required * Unable to give informed consent * 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) * Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution * Inability to comply with the protocol in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Red Blood Cell (RBC) 24-Hour Recovery | 24 hours | To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival | 28 days | Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB. |
| Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%) | 24 hours | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB |
| Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | 24 hours | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB |
| Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C) | 24 hours | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB |
| Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%) | 28 days | Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB |
| Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | 28 days | Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB |
| Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C) | 28 days | Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB |
| Neoantigenicity - Day 21 Direct Antigen Test (DAT) | Day 21 | DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded. |
| Neoantigenicity - Day 21 Indirect Antigen Test (IAT) | Day 21 of Treatment Periods 1 and 2 | Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded. |
| Neoantigenicity - Day 42 Direct Antigen Test (DAT) | Day 42 of Treatment Periods 1 and 2 | DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded. |
| Neoantigenicity - Day 42 Indirect Antigen Test (IAT) | Day 42 of Treatment Periods 1 and 2 | IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded. |
| Red Blood Cell (RBC) Survival by Product | 28 days | Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB. |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | Day 0 | — |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | Day 0 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Mirasol-treated WB Then Untreated WB Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49 | 16 |
| Arm 2: Untreated WB Then Mirasol-treated WB Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) | 13 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm 1: Mirasol-treated WB Then Untreated WB | Arm 2: Untreated WB Then Mirasol-treated WB | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 13 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 11 Participants | 27 Participants |
| Region of Enrollment United States | 16 participants | 13 participants | 29 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 24 | 11 / 24 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Red Blood Cell (RBC) 24-Hour Recovery
To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.
Time frame: 24 hours
Population: All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | Red Blood Cell (RBC) 24-Hour Recovery | 82.51 % 24-hour RBC Recovery | Standard Deviation 3.914 |
| Untreated Control | Red Blood Cell (RBC) 24-Hour Recovery | 91.70 % 24-hour RBC Recovery | Standard Deviation 6.812 |
Secondary
Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival
Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.
Time frame: 28 days
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival | 1715.2 Days * Percent Recovery | Standard Deviation 173.13 |
| Untreated Control | Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival | 2055.2 Days * Percent Recovery | Standard Deviation 158.34 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | 0.248 µmol/mL | Standard Deviation 0.2604 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | 0.333 µmol/mL | Standard Deviation 0.4146 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | 12.289 µmol/mL | Standard Deviation 2.1394 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | 12.499 µmol/mL | Standard Deviation 3.7456 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | 4.659 µmol/g Hgb | Standard Deviation 0.7372 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | 4.544 µmol/g Hgb | Standard Deviation 0.4275 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | 4.416 µmol/g Hgb | Standard Deviation 1.1313 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | 5.403 µmol/g Hgb | Standard Deviation 1.0111 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | 560.3 mg/dL | Standard Deviation 17.62 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | 559.5 mg/dL | Standard Deviation 45.88 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | 408.5 mg/dL | Standard Deviation 30.9 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | 398.6 mg/dL | Standard Deviation 33.84 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | 58.3 volume % of red blood cells | Standard Deviation 2.59 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | 60.5 volume % of red blood cells | Standard Deviation 2.65 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | 59.2 % of volume | Standard Deviation 2.83 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | 61.0 % of volume | Standard Deviation 3.21 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | 0.215 % of volume | Standard Deviation 0.1001 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | 0.150 % of volume | Standard Deviation 0.0606 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | 0.103 % of volume | Standard Deviation 0.0338 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | 0.091 % of volume | Standard Deviation 0.0351 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | 2.39 mmol/L | Standard Deviation 0.623 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | 2.03 mmol/L | Standard Deviation 0.561 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | 17.54 mmol/L | Standard Deviation 2.305 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | 20.34 mmol/L | Standard Deviation 3.092 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | 93.09 mmHg at 37° C | Standard Deviation 11.003 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | 98.43 mmHg at 37° C | Standard Deviation 10.438 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | 59.16 pCO2 (mmHg at 37° C) | Standard Deviation 5.824 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | 66.71 pCO2 (mmHg at 37° C) | Standard Deviation 6.607 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | 6.5537 pH | Standard Deviation 0.04776 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | 6.5662 pH | Standard Deviation 0.04751 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | 6.8070 pH (at 37° C) | Standard Deviation 0.03101 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | 6.8253 pH (at 37° C) | Standard Deviation 0.4117 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | 65.50 mEq/L | Standard Deviation 2.497 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | 36.73 mEq/L | Standard Deviation 3.749 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | 2.17 mEq/L | Standard Deviation 0.497 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | 1.78 mEq/L | Standard Deviation 0.465 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | 99.6 mg/dL | Standard Deviation 47.41 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | 76.7 mg/dL | Standard Deviation 34.6 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | 49.2 mg/dL | Standard Deviation 16.66 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | 47.1 mg/dL | Standard Deviation 17.06 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | 19.4 g/dL | Standard Deviation 1.125 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | 20.04 g/dL | Standard Deviation 1.222 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | 19.26 g/dL | Standard Deviation 1.098 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | 19.90 g/dL | Standard Deviation 1.097 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | 0.004 10E3 cells/µL | Standard Deviation 0.02 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | 0.021 10E3 cells/µL | Standard Deviation 0.0833 |
Secondary
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
Time frame: Day 0
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Treated | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | 0.004 10E3 cells/µL | Standard Deviation 0.0196 |
| Untreated Control | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | 0.000 10E3 cells/µL | Standard Deviation 0 |
Secondary
Neoantigenicity - Day 21 Direct Antigen Test (DAT)
DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.
Time frame: Day 21
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Neoantigenicity - Day 21 Direct Antigen Test (DAT) | 0 Positive results |
| Untreated Control | Neoantigenicity - Day 21 Direct Antigen Test (DAT) | 0 Positive results |
Secondary
Neoantigenicity - Day 21 Indirect Antigen Test (IAT)
Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.
Time frame: Day 21 of Treatment Periods 1 and 2
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Neoantigenicity - Day 21 Indirect Antigen Test (IAT) | 0 Positive results |
| Untreated Control | Neoantigenicity - Day 21 Indirect Antigen Test (IAT) | 0 Positive results |
Secondary
Neoantigenicity - Day 42 Direct Antigen Test (DAT)
DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.
Time frame: Day 42 of Treatment Periods 1 and 2
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Neoantigenicity - Day 42 Direct Antigen Test (DAT) | 0 Positive results |
| Untreated Control | Neoantigenicity - Day 42 Direct Antigen Test (DAT) | 0 Positive results |
Secondary
Neoantigenicity - Day 42 Indirect Antigen Test (IAT)
IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.
Time frame: Day 42 of Treatment Periods 1 and 2
Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Neoantigenicity - Day 42 Indirect Antigen Test (IAT) | 0 Positive results |
| Untreated Control | Neoantigenicity - Day 42 Indirect Antigen Test (IAT) | 0 Positive results |
Secondary
Red Blood Cell (RBC) Survival by Product
Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.
Time frame: 28 days
Population: All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirasol Treated | Red Blood Cell (RBC) Survival by Product | Linear RBC Survival | 60.49 Days | Standard Deviation 5.574 |
| Mirasol Treated | Red Blood Cell (RBC) Survival by Product | Exponential RBC Survival | 46.71 Days | Standard Deviation 5.63 |
| Mirasol Treated | Red Blood Cell (RBC) Survival by Product | Linear T50 | 22.58 Days | Standard Deviation 4.328 |
| Mirasol Treated | Red Blood Cell (RBC) Survival by Product | Exponential T50 | 22.63 Days | Standard Deviation 5.286 |
| Untreated Control | Red Blood Cell (RBC) Survival by Product | Linear T50 | 35.83 Days | Standard Deviation 7.863 |
| Untreated Control | Red Blood Cell (RBC) Survival by Product | Linear RBC Survival | 81.57 Days | Standard Deviation 15.474 |
| Untreated Control | Red Blood Cell (RBC) Survival by Product | Exponential T50 | 39.91 Days | Standard Deviation 10.485 |
| Untreated Control | Red Blood Cell (RBC) Survival by Product | Exponential RBC Survival | 67.81 Days | Standard Deviation 15.492 |
Secondary
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)
Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Time frame: 24 hours
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C) | 0.0383 Spearman's Correlation Coefficient |
| Untreated Control | Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C) | 0.0475 Spearman's Correlation Coefficient |
Secondary
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Time frame: 24 hours
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | 0.6107 Spearman's Correlation Coefficient |
| Untreated Control | Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | 0.4116 Spearman's Correlation Coefficient |
Secondary
Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)
Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Time frame: 24 hours
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%) | -0.1779 Spearman's Correlation Coefficient |
| Untreated Control | Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%) | 0.4286 Spearman's Correlation Coefficient |
Secondary
Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Time frame: 28 days
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | 0.2487 Spearman's Correlation Coefficient |
| Untreated Control | Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | 0.0261 Spearman's Correlation Coefficient |
Secondary
Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)
Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Time frame: 28 days
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%) | -0.0592 Spearman's Correlation Coefficient |
| Untreated Control | Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%) | 0.0564 Spearman's Correlation Coefficient |
Secondary
Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)
Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Time frame: 28 days
Population: All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirasol Treated | Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C) | -0.0691 Spearman's Correlation Coefficient |
| Untreated Control | Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C) | -0.1065 Spearman's Correlation Coefficient |