Trial Outcomes & Findings for Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets (NCT NCT02078284)
NCT ID: NCT02078284
Last Updated: 2021-05-20
Results Overview
Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital sign AEs summarized by severity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
day of thru 6 days after transfusion
Results posted on
2021-05-20
Participant Flow
Patients who were admitted to the site's medical center and undergoing treatment for a hematologic malignancy were potentially eligible for the study. Potential study subjects were recruited by preliminary medical chart review against the study eligibility criteria.
Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
Participant milestones
| Measure |
Cohort 1 With 0.5 Units of CPP
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
5
|
7
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
Baseline characteristics by cohort
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 Participants
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 18.6 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
46.3 years
STANDARD_DEVIATION 16.2 • n=21 Participants
|
51.9 years
STANDARD_DEVIATION 15.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
2 Participants
n=7 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
3 Participants
n=5 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
1 Participants
n=4 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
1 Participants
n=21 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
11 Participants
n=8 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
5 Participants
n=7 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
3 Participants
n=5 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
5 Participants
n=4 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
3 Participants
n=21 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
17 Participants
n=8 Participants • Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1Unit CPP group.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
4 participants
n=21 Participants
|
28 participants
n=8 Participants
|
|
Baseline Weight (kg)
|
91.4 kg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
87.2 kg
STANDARD_DEVIATION 23.9 • n=7 Participants
|
87.7 kg
STANDARD_DEVIATION 28.3 • n=5 Participants
|
97.8 kg
STANDARD_DEVIATION 16.4 • n=4 Participants
|
81.1 kg
STANDARD_DEVIATION 11.4 • n=21 Participants
|
89.5 kg
STANDARD_DEVIATION 20.1 • n=8 Participants
|
|
Baseline Height (cm)
|
171 cm
STANDARD_DEVIATION 2.77 • n=5 Participants
|
172 cm
STANDARD_DEVIATION 8.55 • n=7 Participants
|
176 cm
STANDARD_DEVIATION 11.7 • n=5 Participants
|
180 cm
STANDARD_DEVIATION 11.6 • n=4 Participants
|
177 cm
STANDARD_DEVIATION 13.4 • n=21 Participants
|
175.2 cm
STANDARD_DEVIATION 10.0 • n=8 Participants
|
PRIMARY outcome
Timeframe: day of thru 6 days after transfusionPopulation: Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital sign AEs summarized by severity.
Outcome measures
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 Participants
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Adverse Events (AEs) by Level of Severity
Total number of AEs
|
8 adverse events
|
18 adverse events
|
6 adverse events
|
21 adverse events
|
5 adverse events
|
|
Adverse Events (AEs) by Level of Severity
Total mild AEs
|
6 adverse events
|
11 adverse events
|
1 adverse events
|
9 adverse events
|
5 adverse events
|
|
Adverse Events (AEs) by Level of Severity
Total moderate AEs
|
1 adverse events
|
3 adverse events
|
5 adverse events
|
5 adverse events
|
0 adverse events
|
|
Adverse Events (AEs) by Level of Severity
Total Severe AEs
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Adverse Events (AEs) by Level of Severity
Total Life-threatening or Fatal AEs
|
1 adverse events
|
3 adverse events
|
0 adverse events
|
6 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: day of thru 6 days after transfusionPopulation: Patient 29 was randomized to receive 0.5 Units of CPP but inadvertently received 1 Unit. This patient's data was analyzed with the 1 Unit CPP group.
Number of subjects who experienced AEs at specific levels of severity. Clinical laboratory \[chemistry (serum creatinine, lactate dehydrogenase (LDH), and troponin, and hematology (hemoglobin and hematocrit)\] parameters, physical examination findings, electrocardiogram (ECG)\] and vital signs were evaluated.
Outcome measures
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 Participants
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Total Patients with Any AE
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Total Patients with any AE
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Total Patients with Mild AEs
|
4 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Total Patients with Moderate AEs
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Total Patients with Severe AEss
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Total Patients with Life-threatening or Fatal AEs
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subject Who Experienced Adverse Events (AEs) for a Specific Severity
Related to Investigational Product
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 days after transfusionSubjects with any signs or symptoms of thrombotic events.
Outcome measures
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 Participants
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Number of Subject With Thrombotic Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 up to 6 hrs after transfusion and Day 2 approx 24 hrs after transfusionCorrected Count Increments Expressed in units of mm\^2/(µL\*10¹¹ platelets) (CCI) in the 6 hour period after the study platelet transfusion and on Day 2 (approximately 24 hours after the study platelet transfusion)
Outcome measures
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 Participants
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Corrected Count Increments (CCI)
CII: Day 1 up to 6 hrs after
|
2.40 mm^2/(μL*1011 platelets)
Standard Deviation 5.76
|
3.10 mm^2/(μL*1011 platelets)
Standard Deviation 2.92
|
2.73 mm^2/(μL*1011 platelets)
Standard Deviation 1.51
|
3.70 mm^2/(μL*1011 platelets)
Standard Deviation 2.34
|
14.8 mm^2/(μL*1011 platelets)
Standard Deviation 9.66
|
|
Corrected Count Increments (CCI)
CII: Day 2
|
5.19 mm^2/(μL*1011 platelets)
Standard Deviation 6.22
|
-2.05 mm^2/(μL*1011 platelets)
Standard Deviation 4.96
|
5.63 mm^2/(μL*1011 platelets)
Standard Deviation 7.05
|
2.35 mm^2/(μL*1011 platelets)
Standard Deviation 3.94
|
4.13 mm^2/(μL*1011 platelets)
Standard Deviation 3.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On Day 1 up to 6 hours after transfusion and on Day 2 approximately 24 hours after transfusionCount Increment expressed in units of platelets (x10\^3 µL) (CI)
Outcome measures
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 Participants
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 Participants
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 Participants
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Count Increment
Day 1 Up to 6 Hours After
|
1.20 platelets*10^3 µL
Standard Deviation 3.11
|
3.67 platelets*10^3 µL
Standard Deviation 2.42
|
6.50 platelets*10^3 µL
Standard Deviation 3.89
|
13.2 platelets*10^3 µL
Standard Deviation 6.38
|
30.5 platelets*10^3 µL
Standard Deviation 20.3
|
|
Count Increment
Day 2
|
2.80 platelets*10^3 µL
Standard Deviation 3.11
|
-2.57 platelets*10^3 µL
Standard Deviation 6.40
|
12.5 platelets*10^3 µL
Standard Deviation 14.2
|
10.7 platelets*10^3 µL
Standard Deviation 13.3
|
8.75 platelets*10^3 µL
Standard Deviation 7.97
|
Adverse Events
Cohort 1 With 0.5 Units of CPP
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 2 With 1 Unit of CPP
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 3 With 2 Units of CPP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 With 3 Units of CPP
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
1 Unit of LSP
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Infections and infestations
Worsening lung infection
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Worsening sepsis
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Respiratory, thoracic and mediastinal disorders
Adults respiratory distress syndrome
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Prolonged QT interval
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Sepsis with gram negative rod bacteremia
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Septic shock
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Nervous system disorders
Stroke
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
Other adverse events
| Measure |
Cohort 1 With 0.5 Units of CPP
n=5 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 0.5 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 2 With 1 Unit of CPP
n=7 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 3 With 2 Units of CPP
n=6 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 2 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
Cohort 4 With 3 Units of CPP
n=6 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 3 units of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP)
CPP: One unit of frozen CPP contains approximately 3.4 x 10\^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
|
1 Unit of LSP
n=4 participants at risk
A single 30 to 60 minute intravenous (IV) infusion of 1 unit of liquid stored platelets (LSP)
|
|---|---|---|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
General disorders
Mucosal inflammation
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
25.0%
1/4 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Respiratory rate increased
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
25.0%
1/4 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Psychiatric disorders
Belligerence
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Cardiac murmur
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
General disorders
Chills
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
25.0%
1/4 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
25.0%
1/4 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
25.0%
1/4 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Electocardiogram abnormal
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Reproductive system and breast disorders
Scrotal eodema
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Infections and infestations
Septic shock
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Skin and subcutaneous tissue disorders
Skin odor abnormal
|
20.0%
1/5 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/7 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
16.7%
1/6 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Investigations
Troponin increased
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Day of transfusion thru 6 days after transfusion
|
14.3%
1/7 • Number of events 1 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/6 • Day of transfusion thru 6 days after transfusion
|
0.00%
0/4 • Day of transfusion thru 6 days after transfusion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place