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The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.
This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.
Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:
Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.
Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.
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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, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). |
|
| Double Platelet Product | Experimental | Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trima Accel System | Device | Platelet Apheresis Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL. | The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis |
| Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. | The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis |
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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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131 volunteers signed consent and were enrolled, but 3 were screen fails and therefore did not participate in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Platelet Product | Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure |
| FG001 | Double Platelet Product | Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Safety Population was used to evaluate participant demographics and treatment emergent adverse events (TEAE).
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Platelet Product | Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure |
| BG001 | Double Platelet Product |
| 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 | Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL. | 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 | The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis |
|
Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.
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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, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Citrate Toxicity | Metabolism and nutrition disorders | MedDRA Version 19.0 | Non-systematic Assessment | Metabolism and nutrition disorders including overall and citrate toxicity. |
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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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| Denver |
| Colorado |
| 80230 |
| United States |
Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height (in) | Mean | Standard Deviation | inches |
|
| Weight (lbs) | Mean | Standard Deviation | pounds |
|
| Total Blood Volume (mL) | Mean | Standard Deviation | mililiters |
|
Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
Trima Accel System: Platelet Apheresis Procedure
| OG001 | Double Platelet Product | Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure |
|
|
|
| Primary | Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. | 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 | The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis |
|
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 5 |
| 65 |
| EG001 | Double Platelet Product | Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure | 0 | 63 | 0 | 63 | 2 | 63 |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 19.0 | Non-systematic Assessment | Nervous system disorders including paraesthesia. |
|
| Presyncope | Nervous system disorders | MedDRA Version 19.0 | Non-systematic Assessment | Nervous system disorders including presyncope. |
|
| Injection Site Extravasation | General disorders | MedDRA Version 19.0 | Non-systematic Assessment | General disorders and administration site conditions including injection site extravasation. |
|
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A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.