Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
- Conditions
- Transmission, Blood, Recipient/Donor
- Interventions
- Device: POLFA (Needle Assembly)Device: Kawasumi (Needle Assembly)
- Registration Number
- NCT02476851
- Lead Sponsor
- Haemonetics Corporation
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly) Kawasumi (Needle Assembly) 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. POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly) POLFA (Needle Assembly) 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. POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly) Kawasumi (Needle Assembly) 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. Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly) POLFA (Needle Assembly) 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.
- 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
Trial Locations
- Locations (3)
Hoxworth Blood Center
🇺🇸Cincinnati, Ohio, United States
American Red Cross Mid-Atlantic Region Blood Services
🇺🇸Norfolk, Virginia, United States
Haemonetics
🇺🇸Braintree, Massachusetts, United States