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

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

Detailed Description
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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.

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

Conditions
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Transmission, Blood, Recipient/Donor

Intervention / Treatment
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* Device: POLFA (Needle Assembly)
* Device: Kawasumi (Needle Assembly)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly)<br>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. | Device: POLFA (Needle Assembly)<br>* 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.<br>Device: Kawasumi (Needle Assembly)<br>* 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.<br>|
| Other: Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly)<br>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. | Device: POLFA (Needle Assembly)<br>* 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.<br>Device: Kawasumi (Needle Assembly)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Supernatant Hemoglobin | 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. | Following a one-time whole blood donation, samples were measured within 1 month of donation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Donation, Whole Blood