Trima Accel® System Post Count Algorith… | Clinical Trial

Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego Blood Bank, San Diego, California, United States

About this study

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:

a single platelet product is collected
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trima Accel System

Device

Platelet Apheresis Procedure

Primary outcomes

Donor Postprocedure Platelet Count Following Donation of Single Platelet Product

Time frame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis

The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL.
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product

Time frame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis

The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.

Sponsors and collaborators

Lead sponsor

Terumo BCT

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Feb 18, 2016
Registry last updated: Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed