Trial Outcomes & Findings for IMPACT (Improving Plasma Collection) Clinical Trial (NCT NCT04320823)
NCT ID: NCT04320823
Last Updated: 2021-04-09
Results Overview
The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3443 participants
Primary outcome timeframe
Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.
Results posted on
2021-04-09
Participant Flow
Participant milestones
| Measure |
Experimental Group
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|
|
Overall Study
STARTED
|
1717
|
1726
|
|
Overall Study
COMPLETED
|
1717
|
1726
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=11362 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=11775 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Total
n=23137 Donations
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 11.69 • n=1717 Participants
|
35.4 years
STANDARD_DEVIATION 11.10 • n=1726 Participants
|
35.4 years
STANDARD_DEVIATION 11.40 • n=3443 Participants
|
|
Sex: Female, Male
Female
|
605 Participants
n=1717 Participants
|
601 Participants
n=1726 Participants
|
1206 Participants
n=3443 Participants
|
|
Sex: Female, Male
Male
|
1112 Participants
n=1717 Participants
|
1125 Participants
n=1726 Participants
|
2237 Participants
n=3443 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1717 participants
n=1717 Participants
|
1726 participants
n=1726 Participants
|
3443 participants
n=3443 Participants
|
|
BMI
|
32.1 kg/m^2
STANDARD_DEVIATION 7.74 • n=1717 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 7.75 • n=1726 Participants
|
32.0 kg/m^2
STANDARD_DEVIATION 7.74 • n=3443 Participants
|
|
Weight
|
207.5 lbs
STANDARD_DEVIATION 50.99 • n=1717 Participants
|
206.1 lbs
STANDARD_DEVIATION 51.33 • n=1726 Participants
|
206.8 lbs
STANDARD_DEVIATION 51.16 • n=3443 Participants
|
|
Height
|
67.5 in
STANDARD_DEVIATION 3.60 • n=1717 Participants
|
67.5 in
STANDARD_DEVIATION 3.62 • n=1726 Participants
|
67.5 in
STANDARD_DEVIATION 3.61 • n=3443 Participants
|
|
Donor Status
Repeat
|
1608 Participants
n=1717 Participants
|
1618 Participants
n=1726 Participants
|
3226 Participants
n=3443 Participants
|
|
Donor Status
First-Time
|
109 Participants
n=1717 Participants
|
108 Participants
n=1726 Participants
|
217 Participants
n=3443 Participants
|
|
Hematocrit
|
45.5 percentage of red blood cells
STANDARD_DEVIATION 3.81 • n=1717 Participants
|
45.4 percentage of red blood cells
STANDARD_DEVIATION 3.77 • n=1726 Participants
|
45.5 percentage of red blood cells
STANDARD_DEVIATION 3.79 • n=3443 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome.
Outcome measures
| Measure |
Experimental Group
n=11362 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=11775 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Significant Hypotensive Adverse Events
|
.035 % of significant hypotensive AEs
Interval 0.01 to 0.094
|
.051 % of significant hypotensive AEs
Interval 0.02 to 0.114
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Incidence rate of severe hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, per donation in donors undergoing plasmapheresis. \*Only two severe (1.5) adverse events were observed: one in the experimental group and one in the control group. As the secondary analysis for severe hypotensive adverse events was to be conducted only if there were more than 2 severe hypotensive (vasovagal/hypovolemia) adverse events in any of the two study groups, no formal statistical analysis was performed.
Outcome measures
| Measure |
Experimental Group
n=11362 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=11775 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Severe Hypotensive Adverse Events
|
1 Severe Hypotensive Adverse Events
|
1 Severe Hypotensive Adverse Events
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Population: This analysis was performed on the PP (per protocol) population, defined as all donations where the apheresis procedure was successfully completed collecting at least 90% of target plasma volume as well as all donations associated with a significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings.
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, relative to the actual plasma volume collected. \*The outcome is reported as the expected number of significant hypotensive adverse events per 10,000 L of collected plasma. This outcome was calculated using the total number of significant hypotensive adverse events and the total amount of plasma collected, then normalized to 10,000 L of collected plasma.
Outcome measures
| Measure |
Experimental Group
n=10984 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=11458 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Significant Hypotensive Adverse Events Relative to Volume
|
4.27 No. of AEs per 10,000L of Plasma
|
6.65 No. of AEs per 10,000L of Plasma
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Time from start of plasmapheresis "Begin Draw" to the first significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings.
Outcome measures
| Measure |
Experimental Group
n=11362 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=11775 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Time From Start of Collection to First Significant Hypotensive Adverse Event
|
30.41 minutes
Standard Deviation 16.52
|
51.59 minutes
Standard Deviation 17.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Population: The total number of Participants Analyzed is more than the total population of donors in the study as some donors moved from one bodyweight group to the other throughout their participation in the study. Therefore, this analysis was done at the donation level, based on the bodyweight of each donor at the time of each donation. The number of donations are therefore also listed.
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a bodyweight of less than or equal to 130 lbs and those greater than 130 lbs. \*Note: Due to the absence of AE in the subgroup of donors with bodyweight of ≤130 lbs, no formal statistical analysis was performed.
Outcome measures
| Measure |
Experimental Group
n=251 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=287 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
n=11111 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
n=11488 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Significant Hypotensive Adverse Events Relative to Bodyweight
|
0 % of significant hypotensive AEs
Interval 0.0 to 0.0
|
0 % of significant hypotensive AEs
Interval 0.0 to 0.0
|
.036 % of significant hypotensive AEs
Interval 0.01 to 0.096
|
.052 % of significant hypotensive AEs
Interval 0.02 to 0.117
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Population: The total number of Participants Analyzed is more than the total population of donors in the study as some donors moved from one BMI group to the other throughout their participation in the study. Therefore, this analysis was done at the donation level, based on the BMI of each donor at the time of each donation. The number of donations are therefore also listed.
Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a body mass index (BMI) of less than or equal to 30 and of those greater than 30.
Outcome measures
| Measure |
Experimental Group
n=4638 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=4981 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
n=6724 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
n=6794 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Significant Hypotensive Adverse Events Relative to BMI
|
.043 % of significant hypotensive AEs
Interval 0.001 to 0.168
|
.020 % of significant hypotensive AEs
Interval -0.009 to 0.126
|
.03 % of significant hypotensive AEs
Interval 0.001 to 0.116
|
.074 % of significant hypotensive AEs
Interval 0.026 to 0.178
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their respective status as a first-time donor or repeat donor.
Outcome measures
| Measure |
Experimental Group
n=419 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=405 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
n=10943 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
n=11370 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Significant Hypotensive Adverse Events Relative to Donor Status
|
0 % of significant hypotensive AEs
Interval 0.0 to 1.095
|
.247 % of significant hypotensive AEs
Interval 0.0 to 1.531
|
.037 % of significant hypotensive AEs
Interval 0.011 to 0.098
|
.044 % of significant hypotensive AEs
Interval 0.016 to 0.106
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their gender.
Outcome measures
| Measure |
Experimental Group
n=3485 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=3739 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
n=7877 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
n=8036 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Rate of Significant Hypotensive Adverse Events Relative to Gender
|
.048 % of significant hypotensive AEs
Interval 0.014 to 0.13
|
.07 % of significant hypotensive AEs
Interval 0.028 to 0.155
|
.028 % of significant hypotensive AEs
Interval 0.01 to 0.066
|
.040 % of significant hypotensive AEs
Interval 0.018 to 0.082
|
SECONDARY outcome
Timeframe: Up to approximately 3 months, depending on time of enrollment into the trial.Population: This analysis was performed on the PP (per protocol) population, defined as all donations where the apheresis procedure was successfully completed collecting at least 90% of target plasma volume as well as all donations associated with a significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings.
Total plasma volume collected per procedure.
Outcome measures
| Measure |
Experimental Group
n=10984 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=11458 Donations
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
Experimental Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group With Weight > 130 Lbs
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|---|---|
|
Total Volume
|
841.69 mL
Interval 636.0 to 1000.0
|
777.84 mL
Interval 625.0 to 801.0
|
—
|
—
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group
n=1717 participants at risk
Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.
Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach.
|
Control Group
n=1726 participants at risk
Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.
Current Plasma Collection Approach: Plasma collection using the current collection approach.
|
|---|---|---|
|
Nervous system disorders
IQPP 9.1 Other
|
0.06%
1/1717 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.00%
0/1726 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Respiratory, thoracic and mediastinal disorders
IQPP 8.1 Hyperventilation
|
0.06%
1/1717 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.00%
0/1726 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Immune system disorders
IQPP 7.1 Allergic: Local
|
0.17%
3/1717 • Number of events 3 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.29%
5/1726 • Number of events 5 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Injury, poisoning and procedural complications
IQPP 4.2 Citrate Reaction: Moderate
|
0.06%
1/1717 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.00%
0/1726 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Injury, poisoning and procedural complications
IQPP 4.1 Citrate Reaction: Minor
|
0.12%
2/1717 • Number of events 2 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.17%
3/1726 • Number of events 3 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Injury, poisoning and procedural complications
IQPP 3.3 Local Injury Related to Phlebotomy: Hematoma/Bruise (complicated)
|
0.70%
12/1717 • Number of events 12 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.93%
16/1726 • Number of events 16 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Injury, poisoning and procedural complications
IQPP 3.2 Local Injury Related to Phlebotomy: Hematoma/Bruise (uncomplicated)
|
0.00%
0/1717 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.06%
1/1726 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Injury, poisoning and procedural complications
3.1 Local Injury Related to Phlebotomy: Nerve Irritation
|
0.06%
1/1717 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.17%
3/1726 • Number of events 3 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Vascular disorders
IQPP 1.5 Hypotensive (Vasovagal/Hypovolemia); Severe (With or Without LOC)
|
0.06%
1/1717 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.06%
1/1726 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Vascular disorders
IQPP 1.4 Hypotensive (Vasovagal/Hypovolemia): LOC (prolonged)
|
0.00%
0/1717 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.06%
1/1726 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Vascular disorders
IQPP 1.3 Hypotensive: LOC (brief)
|
0.06%
1/1717 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.06%
1/1726 • Number of events 1 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Vascular disorders
IQPP 1.2 Hypotensive: Prefaint, No LOC (Moderate):
|
0.12%
2/1717 • Number of events 2 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
0.17%
3/1726 • Number of events 3 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
|
Vascular disorders
IQPP 1.1 Hypotensive: Prefaint, No LOC (Minor)
|
3.3%
56/1717 • Number of events 63 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
2.2%
38/1726 • Number of events 42 • Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
|
Additional Information
Jan Hartmann, MD, Vice President of Medical Affairs and Clinical Development
Haemonetics Corporation
Phone: (781) 348 7396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Site and Investigator shall not publish, disclose, present or use for instruction any Results arising out of its conduct of the Study at the Site without the express prior written consent of Sponsor, except to the extent required by applicable law. Sponsor shall have final review and approval rights for any authorized publication by Investigator, including but not limited to publication strategy, publication decisions, publication content and authorship decisions.
- Publication restrictions are in place
Restriction type: OTHER