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

Not Applicable

Completed

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

Detailed Description: The POLFA needle is part of the set's PPD (personal protection device) sampling port assembly that facilitates safer blood transfer between the collection set (i.e., the diversion pouch) and a Vacutainer® for the purpose of viral testing or other testing of the whole blood. The POLFA needle assembly was developed as a means to reduce costs while maintaining functionality, quality and safety. Since the overall functionality of the POLFA needle was designed to be equal to the currently approved Kawasumi needle, a change to the overall device safety and use profile is neither anticipated nor intended.

This trial will serve to generate data sufficient to demonstrate that blood transferred through the POLFA needle results in plasma hemoglobin levels below 100mg/dL.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Plasma Supernatant Hemoglobin	Following a one-time whole blood donation, samples were measured within 1 month of donation.	To determine whether whole blood transferred to a Vacutainer® through the POLFA needle will have supernatant hemoglobin levels \<100 mg/dL within a 95% CI and 95% reliability. The average hemoglobin levels in the blood collected through each assembly is presented.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Haemonetics
🇺🇸
Braintree, Massachusetts, United States
Hoxworth Blood Center
🇺🇸
Cincinnati, Ohio, United States
American Red Cross Mid-Atlantic Region Blood Services
🇺🇸
Norfolk, Virginia, United States
Haemonetics
🇺🇸Braintree, Massachusetts, United States