N/A
N=128
Trima Accel® System Post Count Algorithm Study
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02684630 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Donor Postprocedure Platelet Count Following Donation of Single Platelet Product — 60; 60; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trima Accel System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Donor Postprocedure Platelet Count Following Donation of Single Platelet Product |
60; 60; 0; 0 | — |
| PRIMARY Donor Postprocedure Platelet Count Following Donation of Double Platelet Product |
60; 60; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years.
- Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
- Appears to have adequate venous access to obtain a postprocedure platelet count.
- Has given written informed consent.
Exclusion Criteria
- Has undergone a splenectomy.
Data sourced from ClinicalTrials.gov (NCT02684630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.