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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Haemonetics Corporation
- Enrollment
- 3,443
- Locations
- 3
- Primary Endpoint
- Rate of Significant Hypotensive Adverse Events
Study Overview
Brief Summary
Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 66 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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- •Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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
Arms & Interventions
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.
Intervention: Updated Plasma Collection Feature (Device)
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.
Intervention: Current Plasma Collection Approach (Device)
Outcomes
Primary Outcomes
Rate of Significant Hypotensive Adverse Events
Time Frame: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.
The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome.
Secondary Outcomes
- Rate of Significant Hypotensive Adverse Events Relative to Bodyweight(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Severe Hypotensive Adverse Events(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to Volume(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Time From Start of Collection to First Significant Hypotensive Adverse Event(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to BMI(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to Donor Status(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to Gender(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Total Volume(Up to approximately 3 months, depending on time of enrollment into the trial.)