Trial Outcomes & Findings for Thrombosomes® in Bleeding Thrombocytopenic Patients (NCT NCT03394755)
NCT ID: NCT03394755
Last Updated: 2023-04-14
Results Overview
Overall frequency of (and number and percentage of patients who experience) TEAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
30 days
Results posted on
2023-04-14
Participant Flow
Participant milestones
| Measure |
9.45 x 10^7 Thrombosomes/kg
Cohort 1: Thrombosomes: Freeze-dried platelets
|
1.89 x 10^8 Thrombosomes/kg
Cohort 2: Thrombosomes: Freeze-dried platelets
|
3.78 x 10^8 Thrombosomes/kg
Cohort 3: Thrombosomes: Freeze-dried platelets
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thrombosomes® in Bleeding Thrombocytopenic Patients
Baseline characteristics by cohort
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
378 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
59.5 years
n=7 Participants
|
60.5 years
n=5 Participants
|
59 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Safety Population
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Safety population
Overall frequency of (and number and percentage of patients who experience) TEAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number of Patients With Treatment-Emergent Adverse Events (TEAE)
|
7 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Safety population
Overall frequency of (and number and percentage of patients who experience) TESAEs including serious adverse drug reactions and treatment-related events specifically defining the study's suspension and stopping rules (i.e., thromboembolic events, acute lung injury, anaphylaxis, and death).
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAE)
|
1 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 24 hours, and Day 6 post infusionPopulation: All bleeding sites among the evaluable patient population were grouped into a change in WHO bleeding status rather than by treatment arms.
Grade-level change in WHO bleeding assessment score at most severe bleeding site from baseline; WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding.
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=27 Total bleeding sites
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=27 Total bleeding sites
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=27 Total bleeding sites
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number of WHO Bleeding Sites With Status Change From Baseline
1 hour post infusion
|
0 Total bleeding sites
|
24 Total bleeding sites
|
3 Total bleeding sites
|
|
Number of WHO Bleeding Sites With Status Change From Baseline
6hrs post infusion
|
0 Total bleeding sites
|
21 Total bleeding sites
|
6 Total bleeding sites
|
|
Number of WHO Bleeding Sites With Status Change From Baseline
24 hours post infusion
|
0 Total bleeding sites
|
17 Total bleeding sites
|
10 Total bleeding sites
|
|
Number of WHO Bleeding Sites With Status Change From Baseline
Day 6
|
0 Total bleeding sites
|
10 Total bleeding sites
|
17 Total bleeding sites
|
SECONDARY outcome
Timeframe: Baseline, 1, 6, 24 hours, and Day 6 post infusionPopulation: The evaluable patient population is grouped by WHO grade levels 0, 1, and 2 rather than by treatment arms.
Patients WHO score at primary bleeding site. WHO bleeding assessment score ranges from 1 to 4, with higher numbers indicating worse bleeding. The maximum WHO bleeding assessment score for patients on study was 2.
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=22 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=22 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=22 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site
Baseline
|
0 Participants
|
7 Participants
|
15 Participants
|
|
Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site
1 hour post infusion
|
1 Participants
|
7 Participants
|
14 Participants
|
|
Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site
6 hours post infusion
|
3 Participants
|
7 Participants
|
12 Participants
|
|
Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site
24 hours post infusion
|
4 Participants
|
6 Participants
|
12 Participants
|
|
Number of Patients With Grade-level Change in WHO Bleeding Assessment Score From Baseline - Patients WHO Score at Primary Bleeding Site
Day 6
|
8 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusionPopulation: Safety population
Shift from baseline clinical status of hemoglobin measure at different timepoints post infusion
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
6 Participants
|
7 Participants
|
7 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
1 hour post infusion · Abnormal Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
4 Participants
|
7 Participants
|
7 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
6 hours post infusion · Abnormal Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
24 hours post infusion · Abnormal Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 3 · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 4 · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 5 · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hemoglobin
Day 6 · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusionPopulation: Safety population with available data
Shift from baseline clinical status of hematocrit measure at different timepoints post infusion
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Abnormal CS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Abnormal CS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Abnormal CS>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Abnormal CS>Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Abnormal NCS>Abnormal NCS
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Abnormal NCS>Abnormal CS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Abnormal CS>Abnormal NCS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
6 hours post infusion · Abnormal CS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Abnormal NCS>Abnormal NCS
|
7 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Abnormal NCS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
24 hours post infusion · Abnormal CS>Abnormal NCS
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Abnormal NCS>Abnormal NCS
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Abnormal NCS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Abnormal CS>Abnormal NCS
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 3 · Abnormal CS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Abnormal NCS>Abnormal NCS
|
6 Participants
|
7 Participants
|
5 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Abnormal NCS>Abnormal CS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Abnormal CS>Abnormal NCS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 4 · Abnormal CS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Abnormal NCS>Abnormal NCS
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Abnormal NCS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Abnormal CS>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 5 · Abnormal CS>Abnormal CS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Abnormal NCS>Abnormal NCS
|
6 Participants
|
7 Participants
|
8 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Abnormal NCS>Abnormal CS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Abnormal CS>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
Day 6 · Abnormal CS>Abnormal NCS
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Normal>Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Normal>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Abnormal NCS> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Abnormal NCS>Abnormal NCS
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Patients With a Shift From Baseline in Hematocrit
1 hour post infusion · Abnormal NCS>Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours post infusionPopulation: Safety population with available data
Shift from baseline clinical status of coagulation measure at 24 hours post infusion for each cohort
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Abnormal Not Clinically Significant> Normal
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Normal>Normal
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Normal>Normal
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Time (PT) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Normal>Normal
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
International Normalized Ratio (INR) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Normal>Normal
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Normal>Abnormal Not Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Abnormal Not Clinically Significant> Normal
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Activated Partial Thromboplastin Time (aPTT) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Normal>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
D-dimer · Abnormal Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Normal>Normal
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Normal>Abnormal Not Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Fibrinogen · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Normal>Normal
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Abnormal Not Clinically Significant> Normal
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Antithrombin (TAT) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Normal>Normal
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Prothrombin Fragment (PF) 1+2 · Abnormal Clinically Significant>Abnormal Clinically Significant
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Normal>Normal
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Thrombin Peak Height) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Normal>Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Normal>Abnormal Not Clinically Significant
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Lag Time) · Abnormal Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Normal>Normal
|
7 Participants
|
6 Participants
|
4 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Normal>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Normal>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Abnormal Not Clinically Significant> Normal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Abnormal Not Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Abnormal Not Clinically Significant>Abnormal Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Abnormal Clinically Significant>Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number or Patients With a Shift From Baseline in Coagulation Measures 24 Hours Post Infusion
Thrombin Generation Assay (TGA) (Time to Peak) · Abnormal Clinically Significant>Abnormal Not Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Baseline, 1, 6, 24 hours, Day 3, 4, 5, and 6 post infusionPopulation: The median platelet count of the safety patient population is grouped by timepoints(screening, baseline and post infusion 1, 6, 24 hours, Day 3, 4, 5, 6) rather than by treatment arms.
Median Platelet Counts Per Time Point
Outcome measures
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=24 Participants
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Median Platelet Counts
Day 6
|
18 PLT Count (10³/µl)
Interval 2.0 to 275.0
|
—
|
—
|
|
Median Platelet Counts
Screening
|
16 PLT Count (10³/µl)
Interval 8.0 to 48.0
|
—
|
—
|
|
Median Platelet Counts
Baseline
|
18.5 PLT Count (10³/µl)
Interval 2.0 to 51.0
|
—
|
—
|
|
Median Platelet Counts
1 hour post infusion
|
13.5 PLT Count (10³/µl)
Interval 2.0 to 46.0
|
—
|
—
|
|
Median Platelet Counts
6 hrs post infusion
|
14 PLT Count (10³/µl)
Interval 1.0 to 46.0
|
—
|
—
|
|
Median Platelet Counts
24 hrs post infusion
|
20.5 PLT Count (10³/µl)
Interval 2.0 to 78.0
|
—
|
—
|
|
Median Platelet Counts
Day 3
|
22.5 PLT Count (10³/µl)
Interval 3.0 to 83.0
|
—
|
—
|
|
Median Platelet Counts
Day 4
|
18.5 PLT Count (10³/µl)
Interval 3.0 to 106.0
|
—
|
—
|
|
Median Platelet Counts
Day 5
|
20 PLT Count (10³/µl)
Interval 6.0 to 146.0
|
—
|
—
|
Adverse Events
Thrombosomes 94.5 Million Particles/kg Body Weight
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Thrombosomes 189 Million Particles/kg Body Weight
Serious events: 5 serious events
Other events: 6 other events
Deaths: 3 deaths
Thrombosomes 378 Million Particles/kg Body Weight
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 participants at risk
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 participants at risk
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 participants at risk
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Infections and infestations
Bacteremia
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Infections and infestations
Pathogen resistance
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Infections and infestations
Septic shock
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
General disorders
Fatigue
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
General disorders
Necrosis
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Endocrine disorders
Pituitary haemorrhage
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
Other adverse events
| Measure |
Thrombosomes 94.5 Million Particles/kg Body Weight
n=8 participants at risk
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 189 Million Particles/kg Body Weight
n=8 participants at risk
Thrombosomes: Freeze-dried platelet derived hemostatic
|
Thrombosomes 378 Million Particles/kg Body Weight
n=8 participants at risk
Thrombosomes: Freeze-dried platelet derived hemostatic
|
|---|---|---|---|
|
General disorders
Pyrexia
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
General disorders
Fatigue
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
37.5%
3/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
37.5%
3/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
25.0%
2/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
0.00%
0/8 • All adverse events (AEs) were recorded starting from the day of infusion (Day 1). For non-serious AEs, recording was through the Day 6 visit, and for serious adverse events (SAEs), recording was through the Day 30 visit (phone assessment was acceptable), or until premature discontinuation occurred. AEs were assessed by investigator at visits by physician exam, by vital signs, by laboratory assessments, by chart review, and by open-ended patient query.
Information is reported on treatment-emergent AEs and SAEs (TEAEs and TESAEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place