IMPACT (Improving Plasma Collection) Clinical Trial

Haemonetics

Status: Completed

Conditions: Apheresis Related Hypotension

Treatments: Device: Updated Plasma Collection Feature; Device: Current Plasma Collection Approach

Study type: Interventional

Funder types: Industry

Identifiers

NCT04320823

TP-CLN-100467

Details and patient eligibility

About

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

Full description

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.

Enrollment: 3,443 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Donors must be qualified to donate plasma per individual site's screening procedures which are in compliance with IQPP standards. If donors do not meet inclusion criteria at subsequent donations but have already been enrolled in the clinical trial, they are eligible to remain in the clinical trial and to donate plasma within the clinical trial once they meet eligibility criteria again, except if they fulfill any of the exclusion criteria listed below.

Exclusion criteria

• All subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial.

  • 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  • Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,443 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Device: Updated Plasma Collection Feature

Control Group

Active Comparator group

Description:

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.

Treatment:

Device: Current Plasma Collection Approach