An interventional study of Trima Accel System in Healthy Volunteers, sponsored by Terumo BCT. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-12.
Sponsored by Terumo BCT · Not applicable, Interventional, and Basic science
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.
Terumo BCT is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Device: Trima Accel System
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).
Device: Trima Accel System
Platelet Apheresis Procedure
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.
Time frame: 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.
Time frame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis
| Milestone | Single Platelet Product | Double Platelet Product |
|---|---|---|
| Started | 65 | 63 |
| Completed | 60 | 60 |
| Not completed | 5 | 3 |
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.
| Participants | Single Platelet Product | Double Platelet Product |
|---|---|---|
| Success (n) | 60 | 60 |
| Failure (n) | 0 | 0 |
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.
| Participants | Single Platelet Product | Double Platelet Product |
|---|---|---|
| Success (n) | 60 | 60 |
| Failure (n) | 0 | 0 |
Collected over Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Platelet Product | 0/65 (0%) | 0/65 (0%) | 5/65 (7.7%) |
| Double Platelet Product | 0/63 (0%) | 0/63 (0%) | 2/63 (3.2%) |
| Event | Single Platelet Product | Double Platelet Product |
|---|---|---|
| Citrate ToxicityMetabolism and nutrition disorders | 2/65 | 0/63 |
| ParaesthesiaNervous system disorders | 2/65 | 1/63 |
| PresyncopeNervous system disorders | 0/65 | 1/63 |
| Injection Site ExtravasationGeneral disorders | 1/65 | 0/63 |
The Safety Population was used to evaluate participant demographics and treatment emergent adverse events (TEAE).
| Age, Customized(Participants) | Single Platelet Product | Double Platelet Product | Total |
|---|---|---|---|
| Age ≥ 18 years | 65 | 63 | 128 |
| Sex: Female, Male(Participants) | Single Platelet Product | Double Platelet Product | Total |
|---|---|---|---|
| Female | 23 | 17 | 40 |
| Male | 42 | 46 | 88 |
| Race/Ethnicity, Customized(Participants) | Single Platelet Product | Double Platelet Product | Total |
|---|---|---|---|
| Asian | 1 | 2 | 3 |
| Black | 2 | 2 | 4 |
| Hispanic | 3 | 5 | 8 |
| White | 56 | 53 | 109 |
| Other | 1 | 1 | 2 |
| Unknown | 2 | 0 | 2 |
| Height (in)(inches) | Single Platelet Product | Double Platelet Product | Total |
|---|---|---|---|
| Mean | 68.9 ± 3.95 | 69.0 ± 3.43 | 69.0 ± 3.69 |
| Weight (lbs)(pounds) | Single Platelet Product | Double Platelet Product | Total |
|---|---|---|---|
| Mean | 190.3 ± 37.59 | 191.6 ± 31.23 | 191.0 ± 34.47 |
| Total Blood Volume (mL)(mililiters) | Single Platelet Product | Double Platelet Product | Total |
|---|---|---|---|
| Mean | 5214.3 ± 905.93 | 5285.7 ± 735.86 | 5249.5 ± 824.15 |
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