Trial Outcomes & Findings for Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria (NCT NCT02118428)
NCT ID: NCT02118428
Last Updated: 2019-05-10
Results Overview
Percentage of Participants who contracted transfusion-transmitted malaria (TTM)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
227 participants
Primary outcome timeframe
Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)
Results posted on
2019-05-10
Participant Flow
227 total were enrolled, but one participant was ineligible prior to randomization.
Participant milestones
| Measure |
Mirasol
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
Unassigned
Enrolled subjects who became ineligible prior to randomization to either Mirasol or Control
|
|---|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
1
|
|
Overall Study
Received Study Transfusion
|
111
|
112
|
0
|
|
Overall Study
COMPLETED
|
100
|
104
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
1
|
Reasons for withdrawal
| Measure |
Mirasol
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
Unassigned
Enrolled subjects who became ineligible prior to randomization to either Mirasol or Control
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
|
Overall Study
Death
|
7
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
|
Overall Study
Screen Failure or Became Inelegible
|
1
|
0
|
1
|
Baseline Characteristics
Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria
Baseline characteristics by cohort
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Age, Customized
18-39 years
|
62 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Age, Customized
40-59 years
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
111 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
1.62 meter
STANDARD_DEVIATION 0.08 • n=5 Participants
|
1.63 meter
STANDARD_DEVIATION 0.07 • n=7 Participants
|
1.62 meter
STANDARD_DEVIATION 0.08 • n=5 Participants
|
|
Weight
|
62.7 kilogram
STANDARD_DEVIATION 13.4 • n=5 Participants
|
63.9 kilogram
STANDARD_DEVIATION 12.0 • n=7 Participants
|
63.3 kilogram
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Body Mass Index
|
24.0 kilogram/meter²
STANDARD_DEVIATION 4.9 • n=5 Participants
|
24.2 kilogram/meter²
STANDARD_DEVIATION 4.4 • n=7 Participants
|
24.1 kilogram/meter²
STANDARD_DEVIATION 4.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)Population: Evaluable population = randomized subjects who received up to 2 whole blood transfusions and no non-study blood products, who did not receive any anti-malarial treatment, who had no significant protocol deviations and who additionally were non parasitemic pre-transfusion and received at least one parasitemic fresh whole blood product
Percentage of Participants who contracted transfusion-transmitted malaria (TTM)
Outcome measures
| Measure |
Mirasol
n=28 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=37 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Percentage of Participants With Incidence of Transfusion-transmitted Malaria
|
3.6 Percentage of participants
|
21.6 Percentage of participants
|
SECONDARY outcome
Timeframe: immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusionPopulation: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject. Control products were only sampled post-collection, so no results for post-Mirasol treatment. All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment. All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Bacterial Contamination of Fresh Whole Blood (FWB) Products
Positive post-collection
|
3.3 percentage of blood product samples
Interval 1.2 to 7.0
|
3.2 percentage of blood product samples
Interval 1.2 to 6.9
|
|
Bacterial Contamination of Fresh Whole Blood (FWB) Products
Positive post-Mirasol treatment
|
6.6 percentage of blood product samples
Interval 3.5 to 11.3
|
NA percentage of blood product samples
Control products are not Mirasol treated, so no post-Mirasol sample taken.
|
SECONDARY outcome
Timeframe: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit
Hematocrit, post-collection
|
38.14 percentage
Standard Deviation 3.20
|
38.10 percentage
Standard Deviation 3.03
|
|
Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit
Hematocrit, prior to transfusion
|
35.54 percentage
Standard Deviation 2.81
|
37.66 percentage
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin
Total hemoglobin, post-collection
|
12.98 g/dL
Standard Deviation 1.18
|
12.93 g/dL
Standard Deviation 1.13
|
|
Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin
Total hemoglobin, prior to transfusion
|
11.97 g/dL
Standard Deviation 0.98
|
12.74 g/dL
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count
RBC count, post-collection
|
4.58 Cells x 10e12/L
Standard Deviation 0.49
|
4.57 Cells x 10e12/L
Standard Deviation 0.52
|
|
Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count
RBC count, prior to transfusion
|
4.20 Cells x 10e12/L
Standard Deviation 0.49
|
4.47 Cells x 10e12/L
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Fresh Whole Blood Products - Platelet Count
Platelet count, post-collection
|
156.2 Cells x 10e9/L
Standard Deviation 44.3
|
156.9 Cells x 10e9/L
Standard Deviation 46.2
|
|
Hematology Parameter in Fresh Whole Blood Products - Platelet Count
Platelet count, prior to transfusion
|
85.3 Cells x 10e9/L
Standard Deviation 37.9
|
101.3 Cells x 10e9/L
Standard Deviation 57.2
|
SECONDARY outcome
Timeframe: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count
WBC, post-collection
|
4.32 Cells x 10e9/L
Standard Deviation 1.05
|
4.45 Cells x 10e9/L
Standard Deviation 1.16
|
|
Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count
WBC, prior to transfusion
|
3.69 Cells x 10e9/L
Standard Deviation 1.08
|
3.74 Cells x 10e9/L
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Biochemistry Parameter in Fresh Whole Blood Products - Potassium
Potassium, post-collection
|
3.61 mmol/L
Standard Deviation 2.55
|
3.85 mmol/L
Standard Deviation 3.33
|
|
Biochemistry Parameter in Fresh Whole Blood Products - Potassium
Potassium, prior to transfusion
|
14.97 mmol/L
Standard Deviation 7.71
|
7.16 mmol/L
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 28Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Patients - Hematocrit
Day 0
|
19.69 percentage
Standard Deviation 5.40
|
19.52 percentage
Standard Deviation 5.01
|
|
Hematology Parameter in Patients - Hematocrit
Day 1
|
24.25 percentage
Standard Deviation 5.47
|
24.08 percentage
Standard Deviation 4.21
|
|
Hematology Parameter in Patients - Hematocrit
Day 2
|
24.50 percentage
Standard Deviation 4.48
|
25.48 percentage
Standard Deviation 4.76
|
|
Hematology Parameter in Patients - Hematocrit
Day 3
|
24.72 percentage
Standard Deviation 4.70
|
25.68 percentage
Standard Deviation 4.77
|
|
Hematology Parameter in Patients - Hematocrit
Day 7
|
26.62 percentage
Standard Deviation 4.88
|
26.92 percentage
Standard Deviation 4.62
|
|
Hematology Parameter in Patients - Hematocrit
Day 28
|
28.61 percentage
Standard Deviation 6.20
|
29.68 percentage
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 28Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Patients - Total Hemoglobin
Day 0
|
6.71 g/dL
Standard Deviation 1.97
|
6.71 g/dL
Standard Deviation 1.79
|
|
Hematology Parameter in Patients - Total Hemoglobin
Day 1
|
8.53 g/dL
Standard Deviation 2.02
|
8.49 g/dL
Standard Deviation 1.55
|
|
Hematology Parameter in Patients - Total Hemoglobin
Day 2
|
8.49 g/dL
Standard Deviation 1.58
|
8.83 g/dL
Standard Deviation 1.64
|
|
Hematology Parameter in Patients - Total Hemoglobin
Day 3
|
8.57 g/dL
Standard Deviation 1.58
|
8.91 g/dL
Standard Deviation 1.65
|
|
Hematology Parameter in Patients - Total Hemoglobin
Day 7
|
9.07 g/dL
Standard Deviation 1.75
|
9.18 g/dL
Standard Deviation 1.60
|
|
Hematology Parameter in Patients - Total Hemoglobin
Day 28
|
9.72 g/dL
Standard Deviation 2.17
|
10.14 g/dL
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 28Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Patients - Platelet Count
Day 0
|
238.0 Cells x 10e9/L
Standard Deviation 168.79
|
234.50 Cells x 10e9/L
Standard Deviation 147.03
|
|
Hematology Parameter in Patients - Platelet Count
Day 1
|
202.40 Cells x 10e9/L
Standard Deviation 155.85
|
206.0 Cells x 10e9/L
Standard Deviation 121.47
|
|
Hematology Parameter in Patients - Platelet Count
Day 2
|
229.30 Cells x 10e9/L
Standard Deviation 145.56
|
228.20 Cells x 10e9/L
Standard Deviation 132.68
|
|
Hematology Parameter in Patients - Platelet Count
Day 3
|
235.50 Cells x 10e9/L
Standard Deviation 139.11
|
235.70 Cells x 10e9/L
Standard Deviation 124.79
|
|
Hematology Parameter in Patients - Platelet Count
Day 7
|
324.40 Cells x 10e9/L
Standard Deviation 152.79
|
332.40 Cells x 10e9/L
Standard Deviation 156.16
|
|
Hematology Parameter in Patients - Platelet Count
Day 28
|
269.10 Cells x 10e9/L
Standard Deviation 115.21
|
271.50 Cells x 10e9/L
Standard Deviation 126.15
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 28Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Day 0
|
2.51 Cells x 10e12/L
Standard Deviation 0.75
|
2.52 Cells x 10e12/L
Standard Deviation 0.72
|
|
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Day 1
|
3.05 Cells x 10e12/L
Standard Deviation 0.75
|
3.02 Cells x 10e12/L
Standard Deviation 0.60
|
|
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Day 2
|
3.12 Cells x 10e12/L
Standard Deviation 0.66
|
3.27 Cells x 10e12/L
Standard Deviation 0.71
|
|
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Day 3
|
3.15 Cells x 10e12/L
Standard Deviation 0.70
|
3.30 Cells x 10e12/L
Standard Deviation 0.73
|
|
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Day 7
|
3.35 Cells x 10e12/L
Standard Deviation 0.70
|
3.41 Cells x 10e12/L
Standard Deviation 0.68
|
|
Hematology Parameter in Patients - Red Blood Cell (RBC) Count
Day 28
|
3.60 Cells x 10e12/L
Standard Deviation 0.84
|
3.75 Cells x 10e12/L
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3, 7, 28Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Day 0
|
10.34 Cells x 10e9/L
Standard Deviation 10.01
|
9.94 Cells x 10e9/L
Standard Deviation 6.97
|
|
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Day 1
|
8.71 Cells x 10e9/L
Standard Deviation 5.64
|
8.07 Cells x 10e9/L
Standard Deviation 4.02
|
|
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Day 2
|
7.91 Cells x 10e9/L
Standard Deviation 7.11
|
7.54 Cells x 10e9/L
Standard Deviation 4.80
|
|
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Day 3
|
7.42 Cells x 10e9/L
Standard Deviation 6.42
|
7.09 Cells x 10e9/L
Standard Deviation 4.99
|
|
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Day 7
|
7.15 Cells x 10e9/L
Standard Deviation 7.22
|
7.22 Cells x 10e9/L
Standard Deviation 4.96
|
|
Hematology Parameter in Patients - White Blood Cell (WBC) Count
Day 28
|
5.88 Cells x 10e9/L
Standard Deviation 5.0
|
5.48 Cells x 10e9/L
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Biochemistry Parameter in Patients - Potassium
Day 0
|
4.12 mmol/L
Standard Deviation 0.85
|
4.17 mmol/L
Standard Deviation 0.80
|
|
Biochemistry Parameter in Patients - Potassium
Day 1
|
4.14 mmol/L
Standard Deviation 0.75
|
3.80 mmol/L
Standard Deviation 0.49
|
|
Biochemistry Parameter in Patients - Potassium
Day 2
|
3.90 mmol/L
Standard Deviation 0.69
|
3.97 mmol/L
Standard Deviation 0.63
|
|
Biochemistry Parameter in Patients - Potassium
Day 3
|
4.00 mmol/L
Standard Deviation 0.69
|
3.93 mmol/L
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Coagulation Parameter in Patients - Prothrombin Time
Day 0
|
10.08 seconds
Standard Deviation 3.11
|
10.07 seconds
Standard Deviation 4.02
|
|
Coagulation Parameter in Patients - Prothrombin Time
Day 1
|
10.19 seconds
Standard Deviation 2.86
|
9.71 seconds
Standard Deviation 3.33
|
|
Coagulation Parameter in Patients - Prothrombin Time
Day 2
|
9.36 seconds
Standard Deviation 2.20
|
9.62 seconds
Standard Deviation 2.48
|
|
Coagulation Parameter in Patients - Prothrombin Time
Day 3
|
9.53 seconds
Standard Deviation 2.28
|
9.97 seconds
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Day 0
|
29.61 seconds
Standard Deviation 9.12
|
29.12 seconds
Standard Deviation 9.47
|
|
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Day 1
|
29.89 seconds
Standard Deviation 7.47
|
29.0 seconds
Standard Deviation 10.25
|
|
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Day 2
|
28.54 seconds
Standard Deviation 6.64
|
27.89 seconds
Standard Deviation 6.45
|
|
Coagulation Parameter in Patients - Activated Partial Thromboplastin Time
Day 3
|
28.60 seconds
Standard Deviation 6.33
|
29.68 seconds
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Days 0, 1, 2, 3Population: Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion
INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.
Outcome measures
| Measure |
Mirasol
n=111 Participants
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 Participants
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Coagulation Parameter in Patients - International Normalized Ratio (INR)
Day 0
|
1.05 ratio
Standard Deviation 0.26
|
1.04 ratio
Standard Deviation 0.33
|
|
Coagulation Parameter in Patients - International Normalized Ratio (INR)
Day 1
|
1.07 ratio
Standard Deviation 0.25
|
1.02 ratio
Standard Deviation 0.27
|
|
Coagulation Parameter in Patients - International Normalized Ratio (INR)
Day 2
|
0.99 ratio
Standard Deviation 0.19
|
1.01 ratio
Standard Deviation 0.20
|
|
Coagulation Parameter in Patients - International Normalized Ratio (INR)
Day 3
|
1.00 ratio
Standard Deviation 0.19
|
1.04 ratio
Standard Deviation 0.25
|
Adverse Events
Mirasol
Serious events: 13 serious events
Other events: 33 other events
Deaths: 0 deaths
Control
Serious events: 9 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirasol
n=111 participants at risk
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 participants at risk
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
General disorders
Asthenia
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Atypical pneumonia
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
1.8%
2/112 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Urinary tract infection
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Nervous system disorders
Encephalopathy
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Malaria
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Pelvic abscess
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Pneumonia
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.89%
1/112 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
Other adverse events
| Measure |
Mirasol
n=111 participants at risk
Transfusions with Mirasol-treated whole blood
Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
|
Control
n=112 participants at risk
Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
|
|---|---|---|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
4.5%
5/111 • Number of events 5 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
8.0%
9/112 • Number of events 9 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
3.6%
4/111 • Number of events 4 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
4.5%
5/112 • Number of events 5 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Infections and infestations
Malaria
|
6.3%
7/111 • Number of events 7 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
4.5%
5/112 • Number of events 5 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Vascular disorders
Hypertension
|
4.5%
5/111 • Number of events 5 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
2.7%
3/112 • Number of events 3 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Nervous system disorders
Headache
|
2.7%
3/111 • Number of events 3 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
3.6%
4/112 • Number of events 4 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
4/111 • Number of events 4 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
1.8%
2/112 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
General disorders
Pyrexia
|
1.8%
2/111 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
2.7%
3/112 • Number of events 3 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
General disorders
Chills
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
1.8%
2/112 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Gastrointestinal disorders
Vomiting
|
0.90%
1/111 • Number of events 1 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
1.8%
2/112 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/111 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
1.8%
2/112 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.8%
2/111 • Number of events 2 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
0.00%
0/112 • 28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60