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Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder

NCT02476851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-04-29

Study results available
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Summary

This study evaluates whether whole blood transferred through the new POLFA needle assembly meets supernatant hemoglobin acceptability standards.

Conditions

  • Transmission, Blood, Recipient/Donor

Interventions

DEVICE

POLFA (Needle Assembly)

Each subject receives the same intervention and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied.

DEVICE

Kawasumi (Needle Assembly)

Each subject receives the same intervention and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied.

Sponsors & Collaborators

  • Haemonetics Corporation

    lead INDUSTRY

Principal Investigators

  • Lou Ann Maes, MD · American Red Cross Mid-Atlantic Region

  • Jose Cancelas, MD · Hoxworth Blood Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-07-31
Completion
2015-09-30

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 NCT02476851 on ClinicalTrials.gov