IMPACT (Improving Plasma Collection) Clinical Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-04-27

Brief Summary

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Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.

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Detailed Description

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Prospective, multi-center, randomized, controlled clinical trial that will be conducted at three source plasma collection centers throughout the United States. The objective of the trial is to study the safety and effectiveness of a novel plasma collection nomogram run on the bi-directionally integrated Haemonetics NexSys PCS® and Haemonetics NexLynk DMS® plasma collection system. Subjects will be randomized into an intervention and control arm. The control arm will donate plasma using the current software. The intervention arm will donate plasma using a novel software that supports a more individualized collection approach.

Conditions

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Apheresis Related Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm, randomized, controlled trial

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Group

Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled.

Group Type EXPERIMENTAL

Updated Plasma Collection Feature

Intervention Type DEVICE

Plasma collection using a novel, patented system that supports a more individualized collection approach.

Control Group

Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled.

Group Type ACTIVE_COMPARATOR

Current Plasma Collection Approach

Intervention Type DEVICE

Plasma collection using the current collection approach.

Interventions

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Updated Plasma Collection Feature

Plasma collection using a novel, patented system that supports a more individualized collection approach.

Intervention Type DEVICE

Current Plasma Collection Approach

Plasma collection using the current collection approach.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* Subject not able or willing to give consent to participate in the clinical trial.
* Subject donated plasma outside of the present clinical trial after enrolling in this clinical trial.
* Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.
* In addition, all donors for whom a BMI for use in the PPN feature cannot be reliably calculated will be excluded

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes