Completed

A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors

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What is being tested

Trima Accel System

Device
Who is being recruted

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: January 2016
See protocol details

Summary

Principal SponsorTerumo BCT
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 28, 2016

Actual date on which the first participant was enrolled.

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: 1. a single platelet product is collected 2. a double platelet product is collected, with or without other components. 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.

Official TitleA Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
NCT02684630
Principal SponsorTerumo BCT
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

131 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.
1 exclusion criteria prevent from participating
Has undergone a splenectomy.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Group II

Experimental
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).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

San Diego Blood Bank

San Diego, United StatesOpen San Diego Blood Bank in Google Maps
Suspended

Bonfils Blood Center

Denver, United States
Completed2 Study Centers