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IMPACT (Improving Plasma Collection) Clinical Trial

NCT04320823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3443

Last updated 2021-04-09

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Haemonetics Corporation

    lead INDUSTRY

Principal Investigators

  • Susan F Leitman, MD · National Institutes of Health (NIH)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2020-03-27
Completion
2020-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320823 on ClinicalTrials.gov