Healthy Volunteers
Conditions
Brief summary
To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for leukoreduction (\< 5.0 × 10\^6 residual white blood cells \[WBC\] per transfusable unit).
Detailed description
The study is designed to evaluate changes to the Trima Accel software to ensure the modified software meets the FDA acceptance criteria for leukoreduction and platelet yield. The operating range for the system flow rates, anticoagulant ratios, storage conditions, and centrifugal forces are the same as the currently cleared Trima Accel system. There are no changes to the environment or storage conditions for platelets, therefore, no in vitro or in vivo platelet quality data will be collected. This is a prospective, open-label, multi-center controlled study to evaluate the leukoreduction of platelets stored in platelet additive solution (PAS) collected on the Trima Accel system Version 7.0 software enhancement. Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 single, 93 double and 93 triple platelet product evaluable data points. Evaluable is defined as a completed platelet product that does not meet any of the protocol analysis exclusion criteria. Plateletpheresis will be per site standard practice and per applicable FDA guidelines such as the FDA Collection of Platelets by Automated Methods, December 2007 Guidance for Industry and Pre-storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion, September 2012. Study participation will be up to 30 days and will consist of 1 to 2 visits. Screening may be done within 30 days before the apheresis procedure or combined as a single visit, which includes screening and the apheresis procedure all in 1 day. The entire study should be completed in approximately 16 months.
Interventions
Platelet Apheresis Procedure
Sponsors
Terumo BCT
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older. * Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA guidance and American Association of Blood Banks (AABB) standards. Note: subjects who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused. * Has given written informed consent.
Exclusion criteria
* Has previously donated an evaluable platelet product in this study (CTS 5059).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Within 48 hours of end of donation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Within 48 hours of end of donation | 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. |
Countries
United States
Participant flow
Recruitment details
A participant was considered enrolled upon signing the informed consent form.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 99 |
| 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 | 101 |
| 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 | 100 |
| Unassigned Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). | 35 |
| Total | 335 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 0 | 9 |
| Overall Study | Equipment failure | 0 | 5 | 5 | 7 |
| Overall Study | Protocol Violation | 3 | 2 | 2 | 6 |
| Overall Study | Subject issues not resulting in AE | 0 | 0 | 0 | 12 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned | Total |
|---|---|---|---|---|---|
| Age, Customized Age ≥ 18 years | 99 Participants | 101 Participants | 100 Participants | 35 Participants | 335 Participants |
| Height | 68.6 inches STANDARD_DEVIATION 3.9 | 68.7 inches STANDARD_DEVIATION 3.95 | 69.1 inches STANDARD_DEVIATION 4.04 | 69.5 inches STANDARD_DEVIATION 4.28 | 68.9 inches STANDARD_DEVIATION 3.99 |
| Race/Ethnicity, Customized American Indian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 7 Participants | 6 Participants | 1 Participants | 15 Participants |
| Race/Ethnicity, Customized No Response | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 93 Participants | 86 Participants | 84 Participants | 28 Participants | 291 Participants |
| Region of Enrollment United States | 99 participants | 101 participants | 100 participants | 35 participants | 335 participants |
| Sex: Female, Male Female | 43 Participants | 43 Participants | 43 Participants | 17 Participants | 146 Participants |
| Sex: Female, Male Male | 56 Participants | 58 Participants | 57 Participants | 18 Participants | 189 Participants |
| Weight | 202.25 pounds STANDARD_DEVIATION 42.04 | 205.09 pounds STANDARD_DEVIATION 46.95 | 225.01 pounds STANDARD_DEVIATION 51.3 | 207.45 pounds STANDARD_DEVIATION 51.44 | 210.44 pounds STANDARD_DEVIATION 48.18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 101 | 0 / 100 | 0 / 35 |
| other Total, other adverse events | 10 / 99 | 8 / 101 | 9 / 100 | 10 / 35 |
| serious Total, serious adverse events | 0 / 99 | 0 / 101 | 0 / 100 | 0 / 35 |
Outcome results
Primary
Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level
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.
Time frame: Within 48 hours of end of donation
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Success (N) | 93 Participants |
| Single Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Failure (N) | 0 Participants |
| Double Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Success (N) | 93 Participants |
| Double Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Failure (N) | 0 Participants |
| Triple Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Success (N) | 93 Participants |
| Triple Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | Failure (N) | 0 Participants |
Comparison: Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.
Comparison: Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.
Comparison: Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.
Secondary
Number of Participants With Platelet Units Containing an Acceptable Platelet Yield
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.
Time frame: Within 48 hours of end of donation
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Success (N) | 89 Participants |
| Single Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Failure (N) | 4 Participants |
| Double Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Success (N) | 93 Participants |
| Double Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Failure (N) | 0 Participants |
| Triple Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Success (N) | 93 Participants |
| Triple Platelet Product | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | Failure (N) | 0 Participants |
Comparison: Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.
Comparison: Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.
Comparison: Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.