Trial Outcomes & Findings for Inactivation of Whole Blood With Mirasol (NCT NCT01907906)
NCT ID: NCT01907906
Last Updated: 2015-08-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
24 hours
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
Arm 1: Mirasol-treated Whole Blood (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, leuko-reduced packed red blood cells (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
|
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) Study Exit on Treatment Period 2, Day 49
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Mirasol-treated Whole Blood (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, leuko-reduced packed red blood cells (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
|
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) Study Exit on Treatment Period 2, Day 49
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
1
|
Baseline Characteristics
Inactivation of Whole Blood With Mirasol
Baseline characteristics by cohort
| Measure |
Arm 1: Mirasol-treated WB Then Untreated WB
n=16 Participants
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
|
Arm 2: Untreated WB Then Mirasol-treated WB
n=13 Participants
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)
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Red Blood Cell (RBC) 24-Hour Recovery
|
82.51 % 24-hour RBC Recovery
Standard Deviation 3.914
|
91.70 % 24-hour RBC Recovery
Standard Deviation 6.812
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Red Blood Cell (RBC) Survival by Product
Linear RBC Survival
|
60.49 Days
Standard Deviation 5.574
|
81.57 Days
Standard Deviation 15.474
|
|
Red Blood Cell (RBC) Survival by Product
Linear T50
|
22.58 Days
Standard Deviation 4.328
|
35.83 Days
Standard Deviation 7.863
|
|
Red Blood Cell (RBC) Survival by Product
Exponential RBC Survival
|
46.71 Days
Standard Deviation 5.630
|
67.81 Days
Standard Deviation 15.492
|
|
Red Blood Cell (RBC) Survival by Product
Exponential T50
|
22.63 Days
Standard Deviation 5.286
|
39.91 Days
Standard Deviation 10.485
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival
|
1715.2 Days * Percent Recovery
Standard Deviation 173.13
|
2055.2 Days * Percent Recovery
Standard Deviation 158.34
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: 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.
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
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)
|
-0.1779 Spearman's Correlation Coefficient
|
0.4286 Spearman's Correlation Coefficient
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: 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.
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
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
|
0.6107 Spearman's Correlation Coefficient
|
0.4116 Spearman's Correlation Coefficient
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: 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.
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
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)
|
0.0383 Spearman's Correlation Coefficient
|
0.0475 Spearman's Correlation Coefficient
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)
|
-0.0592 Spearman's Correlation Coefficient
|
0.0564 Spearman's Correlation Coefficient
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
|
0.2487 Spearman's Correlation Coefficient
|
0.0261 Spearman's Correlation Coefficient
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)
|
-0.0691 Spearman's Correlation Coefficient
|
-0.1065 Spearman's Correlation Coefficient
|
SECONDARY outcome
Timeframe: Day 21Population: 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
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.
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=23 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Neoantigenicity - Day 21 Direct Antigen Test (DAT)
|
0 Positive results
|
0 Positive results
|
SECONDARY outcome
Timeframe: Day 21 of Treatment Periods 1 and 2Population: 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
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.
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=23 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Neoantigenicity - Day 21 Indirect Antigen Test (IAT)
|
0 Positive results
|
0 Positive results
|
SECONDARY outcome
Timeframe: Day 42 of Treatment Periods 1 and 2Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
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.
Outcome measures
| Measure |
Mirasol Treated
n=23 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Neoantigenicity - Day 42 Direct Antigen Test (DAT)
|
0 Positive results
|
0 Positive results
|
SECONDARY outcome
Timeframe: Day 42 of Treatment Periods 1 and 2Population: 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.
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.
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Neoantigenicity - Day 42 Indirect Antigen Test (IAT)
|
0 Positive results
|
0 Positive results
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
|
59.2 % of volume
Standard Deviation 2.83
|
61.0 % of volume
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=25 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
|
58.3 volume % of red blood cells
Standard Deviation 2.59
|
60.5 volume % of red blood cells
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
|
4.659 µmol/g Hgb
Standard Deviation 0.7372
|
4.544 µmol/g Hgb
Standard Deviation 0.4275
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
|
4.416 µmol/g Hgb
Standard Deviation 1.1313
|
5.403 µmol/g Hgb
Standard Deviation 1.0111
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
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
|
0.000 10E3 cells/µL
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=25 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
|
0.004 10E3 cells/µL
Standard Deviation 0.0200
|
0.021 10E3 cells/µL
Standard Deviation 0.0833
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
|
19.4 g/dL
Standard Deviation 1.125
|
20.04 g/dL
Standard Deviation 1.222
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=25 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
|
19.26 g/dL
Standard Deviation 1.098
|
19.90 g/dL
Standard Deviation 1.097
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
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
|
6.8253 pH (at 37° C)
Standard Deviation 0.4117
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=25 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
|
6.5537 pH
Standard Deviation 0.04776
|
6.5662 pH
Standard Deviation 0.04751
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
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
|
66.71 pCO2 (mmHg at 37° C)
Standard Deviation 6.607
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=25 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
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
|
98.43 mmHg at 37° C
Standard Deviation 10.438
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
|
2.17 mEq/L
Standard Deviation 0.497
|
1.78 mEq/L
Standard Deviation 0.465
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
|
65.50 mEq/L
Standard Deviation 2.497
|
36.73 mEq/L
Standard Deviation 3.749
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
|
560.3 mg/dL
Standard Deviation 17.62
|
559.5 mg/dL
Standard Deviation 45.88
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
|
408.5 mg/dL
Standard Deviation 30.90
|
398.6 mg/dL
Standard Deviation 33.84
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=26 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
|
2.39 mmol/L
Standard Deviation 0.623
|
2.03 mmol/L
Standard Deviation 0.561
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
|
17.54 mmol/L
Standard Deviation 2.305
|
20.34 mmol/L
Standard Deviation 3.092
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
|
49.2 mg/dL
Standard Deviation 16.66
|
47.1 mg/dL
Standard Deviation 17.06
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
|
99.6 mg/dL
Standard Deviation 47.41
|
76.7 mg/dL
Standard Deviation 34.60
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
|
12.289 µmol/mL
Standard Deviation 2.1394
|
12.499 µmol/mL
Standard Deviation 3.7456
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
|
0.248 µmol/mL
Standard Deviation 0.2604
|
0.333 µmol/mL
Standard Deviation 0.4146
|
SECONDARY outcome
Timeframe: Day 0Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
|
0.103 % of volume
Standard Deviation 0.0338
|
0.091 % of volume
Standard Deviation 0.0351
|
SECONDARY outcome
Timeframe: Day 21Population: All subjects who signed an IC Form (were enrolled), and had samples available for the requested test
Outcome measures
| Measure |
Mirasol Treated
n=24 Participants
LR-pRBCs derived from Mirasol-treated WB
|
Untreated Control
n=24 Participants
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
|
0.215 % of volume
Standard Deviation 0.1001
|
0.150 % of volume
Standard Deviation 0.0606
|
Adverse Events
Mirasol Treated
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Untreated Control
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirasol Treated
n=24 participants at risk；n=29 participants at risk
LR-pRBCs derived from Mirasol-treated WB.
|
Untreated Control
n=24 participants at risk；n=29 participants at risk
LR-pRBCs derived from untreated WB
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
General disorders
Vessel puncture site bruise
|
20.8%
5/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
20.8%
5/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
General disorders
Inflammation
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
General disorders
Infusion site bruising
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
4/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
20.8%
5/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Infections and infestations
Cystitis
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Investigations
Haematocrit decreased
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Nervous system disorders
Sinus headache
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Nervous system disorders
Tension headache
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
|
Vascular disorders
Peripheral coldness
|
4.2%
1/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
0.00%
0/24 • All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj). SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
|
Additional Information
Ray Goodrich, PhD
Terumo BCT Biotechnologies, LLC
Phone: (303) 231-4832
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60