NCT02476851

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Haemonetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Transmission, Blood, Recipient/Donor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2015-06-19
• Last updated: 2022-04-29
• Results posted: 2022-04-29

Locations

3 sites across 1 country: United States