Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
1 other identifier
interventional
62
1 country
3
Brief Summary
This study evaluates whether whole blood transferred through the new POLFA needle assembly meets supernatant hemoglobin acceptability standards.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
April 29, 2022
CompletedApril 29, 2022
April 1, 2022
1 month
June 11, 2015
November 26, 2021
April 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly)
OTHEREnsure 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)
OTHEREnsure 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.
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Haemonetics
Braintree, Massachusetts, 02184, United States
Hoxworth Blood Center
Cincinnati, Ohio, 45267, United States
American Red Cross Mid-Atlantic Region Blood Services
Norfolk, Virginia, 23507, United States
Results Point of Contact
- Title
- Jan Hartmann, MD
- Organization
- Haemonetics Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Lou Ann Maes, MD
American Red Cross Mid-Atlantic Region
- PRINCIPAL INVESTIGATOR
Jose Cancelas, MD
Hoxworth Blood Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 19, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
April 29, 2022
Results First Posted
April 29, 2022
Record last verified: 2022-04