Clinical trial NCT02476851: Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
Official title: Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transmission, Blood, Recipient/Donor
Keywords: Blood Donation
Whole Blood
Lead sponsor: Haemonetics Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Plasma Supernatant Hemoglobin
timeFrame: Following a one-time whole blood donation, samples were measured within 1 month of donation.
Secondary outcomes:
Other outcomes:
Locations:
city: Braintree
country: United States
facility: Haemonetics
state: Massachusetts
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Norfolk
country: United States
facility: American Red Cross Mid-Atlantic Region Blood Services
state: Virginia
Study officials:
affiliation: American Red Cross Mid-Atlantic Region
name: Lou Ann Maes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoxworth Blood Center
name: Jose Cancelas, MD
role: PRINCIPAL_INVESTIGATOR
References: