Trial Outcomes & Findings for Evaluation of Trima Version 7.0 Platelets in PAS (NCT NCT02754440)
NCT ID: NCT02754440
Last Updated: 2018-05-11
Results Overview
The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level \< 5.0 × 10\^6; doubles = residual WBC level \< 8.0 × 10\^6 or \< 5.0 × 10\^6 for each transfusable unit; and triples = residual WBC level \< 12.0 × 10\^6 or \< 5.0 × 10\^6 for each transfusable unit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
365 participants
Primary outcome timeframe
Within 48 hours of end of donation
Results posted on
2018-05-11
Participant Flow
A participant was considered "enrolled" upon signing the informed consent form.
365 participants consented/enrolled: 25 screen-failed; 5 never started procedure = 30 participants excluded from Safety Analysis. 335 participants = Safety Analysis set (56 participants excluded from the full analysis set: 35 participants were "unassigned" to an Arm, 21 participants were assigned to an Arm) 279 = Full Analysis set
Participant milestones
| Measure |
Single Platelet Product
Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Double Platelet Product
Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Triple Platelet Product
Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Unassigned
Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
100
|
35
|
|
Overall Study
COMPLETED
|
93
|
93
|
93
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
7
|
35
|
Reasons for withdrawal
| Measure |
Single Platelet Product
Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Double Platelet Product
Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Triple Platelet Product
Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Unassigned
Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
2
|
6
|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Equipment failure
|
0
|
5
|
5
|
7
|
|
Overall Study
Subject issues not resulting in AE
|
0
|
0
|
0
|
12
|
Baseline Characteristics
Evaluation of Trima Version 7.0 Platelets in PAS
Baseline characteristics by cohort
| Measure |
Single Platelet Product
n=99 Participants
Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Double Platelet Product
n=101 Participants
Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Triple Platelet Product
n=100 Participants
Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Unassigned
n=35 Participants
Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age ≥ 18 years
|
99 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
335 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
291 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
No Response
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
101 participants
n=7 Participants
|
100 participants
n=5 Participants
|
35 participants
n=4 Participants
|
335 participants
n=21 Participants
|
|
Height
|
68.6 inches
STANDARD_DEVIATION 3.90 • n=5 Participants
|
68.7 inches
STANDARD_DEVIATION 3.95 • n=7 Participants
|
69.1 inches
STANDARD_DEVIATION 4.04 • n=5 Participants
|
69.5 inches
STANDARD_DEVIATION 4.28 • n=4 Participants
|
68.9 inches
STANDARD_DEVIATION 3.99 • n=21 Participants
|
|
Weight
|
202.25 pounds
STANDARD_DEVIATION 42.04 • n=5 Participants
|
205.09 pounds
STANDARD_DEVIATION 46.95 • n=7 Participants
|
225.01 pounds
STANDARD_DEVIATION 51.3 • n=5 Participants
|
207.45 pounds
STANDARD_DEVIATION 51.44 • n=4 Participants
|
210.44 pounds
STANDARD_DEVIATION 48.18 • n=21 Participants
|
PRIMARY outcome
Timeframe: Within 48 hours of end of donationPopulation: The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.
The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level \< 5.0 × 10\^6; doubles = residual WBC level \< 8.0 × 10\^6 or \< 5.0 × 10\^6 for each transfusable unit; and triples = residual WBC level \< 12.0 × 10\^6 or \< 5.0 × 10\^6 for each transfusable unit.
Outcome measures
| Measure |
Single Platelet Product
n=93 Participants
Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Double Platelet Product
n=93 Participants
Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Triple Platelet Product
n=93 Participants
Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
|---|---|---|---|
|
Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level
Success (N)
|
93 Participants
|
93 Participants
|
93 Participants
|
|
Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level
Failure (N)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours of end of donationPopulation: The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.
The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10\^11 for singles, platelet yield ≥ 6.2 × 10\^11 for doubles, and platelet yield ≥ 9.3 × 10\^11 for triples.
Outcome measures
| Measure |
Single Platelet Product
n=93 Participants
Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Double Platelet Product
n=93 Participants
Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Triple Platelet Product
n=93 Participants
Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
|---|---|---|---|
|
Number of Participants With Platelet Units Containing an Acceptable Platelet Yield
Success (N)
|
89 Participants
|
93 Participants
|
93 Participants
|
|
Number of Participants With Platelet Units Containing an Acceptable Platelet Yield
Failure (N)
|
4 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Single Platelet Product
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Double Platelet Product
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Triple Platelet Product
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Unassigned
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Platelet Product
n=99 participants at risk
Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Double Platelet Product
n=101 participants at risk
Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Triple Platelet Product
n=100 participants at risk
Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.
Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure
|
Unassigned
n=35 participants at risk
Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis).
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Citrate Toxicity
|
10.1%
10/99 • Number of events 10 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
7.9%
8/101 • Number of events 8 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
9.0%
9/100 • Number of events 9 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
0.00%
0/35 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
|
Vascular disorders
Hematoma
|
0.00%
0/99 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
0.00%
0/101 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
0.00%
0/100 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
22.9%
8/35 • Number of events 8 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
|
General disorders
Injection Site Extravasation
|
0.00%
0/99 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
0.00%
0/101 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
0.00%
0/100 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
5.7%
2/35 • Number of events 2 • Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion.
Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor retains the right to review and comment on any public disclosure of study results. If no response is received within 30 days, the Principal Investigator may presume that the submission for publication may proceed without delay. If the Sponsor asks to defer publication, Study Site shall not publish, or otherwise disclose to any third party, any of the information contained in the publication or presentation until such time as permission is granted from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER