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

Haemonetics

Status

Completed

Conditions

Transmission, Blood, Recipient/Donor

Treatments

Device: Kawasumi (Needle Assembly)

Device: POLFA (Needle Assembly)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02476851

TP-CLN-100380

Details and patient eligibility

About

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

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

Study donor must be ≥ 18 years of age.
Study donor must weigh ≥ 110 pounds.
Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).
Study donor's hemoglobin must be ≥12.5 g/dL.
Study donor's hematocrit must be ≥ 38%.
Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR).
Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation.
Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation.
Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures.
Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement.
Study donors must not have experienced any of the following:

Physical trauma consistent with associated coagulopathy within the last 30 days, Surgery within the last 30 days, Known history of hypercoagulopathy (i.e., Factor V Leiden, Prothrombin G20210A, idiopathic venous thrombotic events, etc.).

Female study donors must not be pregnant, expected to be pregnant or breastfeeding.

Exclusion Criteria - any individual not meeting the above criteria.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

62 participants in 2 patient groups

POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly)

Other group

Description:

Ensure that whole blood passed through the POLFA needle assembly (the investigational needle assembly or "INA") has a supernatant hemoglobin within the acceptable range of \< 100mg/dL. Each subject receives the same intervention (Standard of Care blood draw) and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied.

Treatment:

Device: Kawasumi (Needle Assembly)

Device: POLFA (Needle Assembly)

Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly)

Other group

Description:

Treatment:

Device: Kawasumi (Needle Assembly)

Device: POLFA (Needle Assembly)