N/A N=310 Other

Evaluation of Trima Version 7.0 Platelets in 100% Plasma

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT02754492 ↗

Enrolled (actual)

310

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level — 92; 93; 93; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Trima Accel System with Version 7.0 Software (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Terumo BCT
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level	92; 93; 93; 1; 0; 0	—
SECONDARY Number of Participants With Platelet Units Containing an Acceptable Platelet Yield	92; 93; 93; 1; 0; 0	—

Summary

To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

Eligibility Criteria

Inclusion Criteria

Age 18 years or older.
Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with plasma collection on the Trima Accel system. These criteria are based on FDA guidance and the 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, as products are not transfused.
Has given written informed consent.

Exclusion Criteria

Has previously donated an evaluable platelet product in this study (CTS 5060).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02754492). 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.