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Completed

NCT Number: NCT04320823

IMPACT (Improving Plasma Collection) Clinical Trial

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

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Key information

Conditions

Apheresis Related Hypotension

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Octapharma Plasma, Wichita, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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

Treatment and study plan

Updated Plasma Collection Feature

Device

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

Current Plasma Collection Approach

Device

Plasma collection using the current collection approach.

Primary outcomes

  1. 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

  1. Rate of Severe Hypotensive Adverse Events

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  2. Rate of Significant Hypotensive Adverse Events Relative to Volume

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  3. Time From Start of Collection to First Significant Hypotensive Adverse Event

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  4. Rate of Significant Hypotensive Adverse Events Relative to Bodyweight

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  5. Rate of Significant Hypotensive Adverse Events Relative to BMI

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  6. Rate of Significant Hypotensive Adverse Events Relative to Donor Status

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  7. Rate of Significant Hypotensive Adverse Events Relative to Gender

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    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.

  8. Total Volume

    Time frame: Up to approximately 3 months, depending on time of enrollment into the trial.

    Total plasma volume collected per procedure.

Sponsors and collaborators

Lead sponsor

Haemonetics Corporation

Industry

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2020
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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