N/A
Completed N=85
In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
Healthy Volunteers
Source: ClinicalTrials.gov NCT02298842 ↗
Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: pH of Platelets at Day 5 — 7.184; 7.414 pH
Summary
This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY pH of Platelets at Day 5 |
7.184; 7.414 | — |
| PRIMARY pH of Platelets at Day 7 |
7.152; 7.335 | — |
| SECONDARY Percent of Platelets Activated as Measured by P-selectin |
29.392; 14.232 | — |
| SECONDARY Percent of Extent of Shape Change |
19.328; 27.962 | — |
| SECONDARY Percent of Platelets Exhibiting Hypotonic Shock Response |
37.038; 49.284 | — |
| SECONDARY Platelet Morphology |
269.7; 282.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years of age or older
- Meet the inclusion criteria defined by the Investigational Site for an apheresis double platelet with plasma collection on the Trima Accel System. These criteria are based on American Association of Blood Banks (AABB) standards. Note: Subjects who are deferred from volunteer community donations because of travel restrictions, piercings or tattoos may participate in the study.
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT02298842). 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.