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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Platelet Product | Experimental | 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. |
|
| Double Platelet Product | Experimental | 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. |
|
| Triple Platelet Product | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trima Accel System with Version 7.0 Software | Device | Platelet Apheresis Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 hours of end of donation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 hours of end of donation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Pidcoke, MD, PhD | Terumo BCT, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Blood Bank | San Diego | California | 92102 | United States | ||
| Bonfils Blood Center |
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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
A participant was considered "enrolled" upon signing the informed consent form.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Unassigned | Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set = Includes all Subjects that had an apheresis procedure started.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Within 48 hours of end of donation |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Citrate Toxicity | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Pidcoke, MD, PhD | Terumo BCT, Inc. | (303) 231-4805 | Heather.Pidcoke@terumobct.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2016 | Dec 8, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2016 | Dec 8, 2017 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2017 | Dec 8, 2017 | SAP_002.pdf |
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| Denver |
| Colorado |
| 80230 |
| United States |
| Indiana Blood Center | Indianapolis | Indiana | 46208 | United States |
| Memorial Blood Centers | Minneapolis | Minnesota | 55114 | United States |
| Community Blood Center of Greater Kansas | Kansas City | Missouri | 64111-2390 | United States |
| Hoxworth Blood Center | Cincinnati | Ohio | 45267 | United States |
| Blood Center of Wisconsin | Milwaukee | Wisconsin | 53233 | United States |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Equipment failure |
|
| Subject issues not resulting in AE |
|
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Unassigned | Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| OG001 | 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 |
| OG002 | 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 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Within 48 hours of end of donation |
|
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 10 |
| 99 |
| EG001 | 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 | 0 | 101 | 0 | 101 | 8 | 101 |
| EG002 | 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 | 0 | 100 | 0 | 100 | 9 | 100 |
| EG003 | Unassigned | Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). | 0 | 35 | 0 | 35 | 10 | 35 |
| Hematoma | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection Site Extravasation | General disorders | MedDRA (18.0) | Systematic Assessment |
|
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.
| 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. | Simple Sample Proportion | 1.00 | Standard Error of the Mean | 0 | 1-Sided | 95 | 0.968 | When estimated proportion is 100%, standard error of the mean is estimated as 0. | Other | A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%. |
| 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. | Simple Sample Proportion | 1.00 | Standard Error of the Mean | 0 | 1-Sided | 95 | 0.968 | When estimated proportion is 100%, standard error of the mean is estimated as 0. | Other | A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%. |