Trima Accel® System Post Count Algorithm Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-28

Study Completion Date

2016-05-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single Platelet Product

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).

Group Type EXPERIMENTAL

Trima Accel System

Intervention Type DEVICE

Platelet Apheresis Procedure

Double Platelet Product

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 Type EXPERIMENTAL

Trima Accel System

Intervention Type DEVICE

Platelet Apheresis Procedure

Interventions

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