IMPACT (Improving Plasma Collection) Clinical Trial

NCT04320823 | Completed Results DMC FDA Device

• 1 other identifier: TP-CLN-100467
• Study Type: interventional
• Target: 3,443
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Apheresis Related Hypotension

Keywords

Plasmapheresis (Source plasma collection)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 Bodyweight

  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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Updated Plasma Collection Feature DEVICE

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

Experimental Group

Current Plasma Collection Approach DEVICE

Plasma collection using the current collection approach.

Control Group

Eligibility Criteria

• Age: 18 Years - 66 Years
• Gender Eligibility Details: Donors must indicate their biological gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Haemonetics Corporation: lead

Study Sites (3)

Octapharma Plasma

Wichita, Kansas, 67214, United States

Location

Octapharma Plasma

Charlotte, North Carolina, 28217, United States

Location

Octapharma Plasma

Spokane, Washington, 99208, United States

Location

Related Publications (1)

• 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.

  PMID: 33760230 DERIVED

Results Point of Contact

• Title: Jan Hartmann, MD, Vice President of Medical Affairs and Clinical Development
• Organization: Haemonetics Corporation

Jan.Hartmann@haemonetics.com

(781) 348 7396

Study Officials

• Susan F Leitman, MD

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm, randomized, controlled trial

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: March 25, 2020
• Study Start: January 6, 2020
• Primary Completion: March 27, 2020
• Study Completion: April 27, 2020
• Last Updated: April 9, 2021
• Results First Posted: April 9, 2021

Record last verified: 2021-03

Locations

US (3)