N/A
Completed N=128
Trima Accel® System Post Count Algorithm Study
Healthy Volunteers
Source: ClinicalTrials.gov NCT02684630 ↗
Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Donor Postprocedure Platelet Count Following Donation of Single Platelet Product — 60; 60; 0; 0 Participants
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.
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 | — |
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. Informational only — not medical advice.