IMPACT (Improving Plasma Collection) Clinical Trial

Prospective, Randomized, Controlled, Multicenter Clinical Trial to Demonstrate the Safety and Effectiveness of the NexSys® PCS Plasma Collection System With the Percent Plasma Nomogram (PPN) Feature

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

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.

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  • Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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