IMPACT (Improving Plasma Collection) Clinical Trial

Study Overview
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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.

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.

Official Title
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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

Conditions
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Apheresis Related Hypotension

Intervention / Treatment
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* Device: Updated Plasma Collection Feature
* Device: Current Plasma Collection Approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm, randomized, controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Device: Updated Plasma Collection Feature<br>* Plasma collection using a novel, patented system that supports a more individualized collection approach.<br>|
| Active Comparator: Control Group<br>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. | Device: Current Plasma Collection Approach<br>* Plasma collection using the current collection approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Significant Hypotensive Adverse Events | 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. | Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Severe Hypotensive Adverse Events | Incidence rate of severe hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, per donation in donors undergoing plasmapheresis. *Only two severe (1.5) adverse events were observed: one in the experimental group and one in the control group. As the secondary analysis for severe hypotensive adverse events was to be conducted only if there were more than 2 severe hypotensive (vasovagal/hypovolemia) adverse events in any of the two study groups, no formal statistical analysis was performed. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Rate of Significant Hypotensive Adverse Events Relative to Volume | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, relative to the actual plasma volume collected. *The outcome is reported as the expected number of significant hypotensive adverse events per 10,000 L of collected plasma. This outcome was calculated using the total number of significant hypotensive adverse events and the total amount of plasma collected, then normalized to 10,000 L of collected plasma. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Time From Start of Collection to First Significant Hypotensive Adverse Event | Time from start of plasmapheresis Begin Draw to the first significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a bodyweight of less than or equal to 130 lbs and those greater than 130 lbs. *Note: Due to the absence of AE in the subgroup of donors with bodyweight of ≤130 lbs, no formal statistical analysis was performed. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Rate of Significant Hypotensive Adverse Events Relative to BMI | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a body mass index (BMI) of less than or equal to 30 and of those greater than 30. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Rate of Significant Hypotensive Adverse Events Relative to Donor Status | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their respective status as a first-time donor or repeat donor. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Rate of Significant Hypotensive Adverse Events Relative to Gender | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their gender. | Up to approximately 3 months, depending on time of enrollment into the trial. | 
| Total Volume | Total plasma volume collected per procedure. | Up to approximately 3 months, depending on time of enrollment into the trial. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasmapheresis (Source plasma collection)