Clinical trial NCT04320823: IMPACT (Improving Plasma Collection) Clinical Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apheresis Related Hypotension
Keywords: Plasmapheresis (Source plasma collection)
Lead sponsor: Haemonetics Corporation
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 3443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, randomized, controlled trial
Primary purpose: OTHER

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.

Eligibility criteria: 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  * Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.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

Primary outcomes:
measure: Rate of Significant Hypotensive Adverse Events
timeFrame: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.
Secondary outcomes:
measure: Rate of Severe Hypotensive Adverse Events
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Rate of Significant Hypotensive Adverse Events Relative to Volume
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Time From Start of Collection to First Significant Hypotensive Adverse Event
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Rate of Significant Hypotensive Adverse Events Relative to Bodyweight
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Rate of Significant Hypotensive Adverse Events Relative to BMI
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Rate of Significant Hypotensive Adverse Events Relative to Donor Status
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Rate of Significant Hypotensive Adverse Events Relative to Gender
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
measure: Total Volume
timeFrame: Up to approximately 3 months, depending on time of enrollment into the trial.
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Octapharma Plasma
state: Kansas
city: Charlotte
country: United States
facility: Octapharma Plasma
state: North Carolina
city: Spokane
country: United States
facility: Octapharma Plasma
state: Washington
Study officials:
affiliation: National Institutes of Health (NIH)
name: Susan F Leitman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF. Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram. Transfusion. 2021 Jun;61(6):1789-1798. doi: 10.1111/trf.16389. Epub 2021 Apr 21.