NCT04320823

IMPACT (Improving Plasma Collection) Clinical Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,443 (actual)
• Sponsor: Haemonetics Corporation · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Accepted

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.

Conditions

• Apheresis Related Hypotension

Interventions

Type	Name	Description
DEVICE	Updated Plasma Collection Feature	Plasma collection using a novel, patented system that supports a more individualized collection approach.
DEVICE	Current Plasma Collection Approach	Plasma collection using the current collection approach.

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-03-27
• Completion: 2020-04-27
• First posted: 2020-03-25
• Last updated: 2021-04-09
• Results posted: 2021-04-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study