Transmission, Blood, Recipient/DonorNCT02476851
Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
A study testing POLFA (Needle Assembly) and Kawasumi (Needle Assembly) in people with Transmission, Blood, Recipient/Donor, run by Haemonetics Corporation at 3 sites in United States.
Trial summary
This study evaluates whether whole blood transferred through the new POLFA needle assembly meets supernatant hemoglobin acceptability standards. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transmission, Blood, Recipient/Donor
- What is being tested?
- POLFA (Needle Assembly) and Kawasumi (Needle Assembly)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
3 sites in 1 country.
United States3 sites
Haemonetics
Braintree, Massachusetts, 02184
Hoxworth Blood Center
Cincinnati, Ohio, 45267
American Red Cross Mid-Atlantic Region Blood Services
Norfolk, Virginia, 23507
About this study
This study evaluates whether whole blood transferred through the new POLFA needle assembly meets supernatant hemoglobin acceptability standards.
Read the 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.
- Conditions
- Transmission, Blood, Recipient/Donor
- Being tested
- POLFA (Needle Assembly), Kawasumi (Needle Assembly)
- Keywords
- Blood Donation, Whole Blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLFA (Needle Assembly)Device
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.
Kawasumi (Needle Assembly)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly) | Other | 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. Receives: Device: POLFA (Needle Assembly); Device: Kawasumi (Needle Assembly) |
| Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly) | Other | 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. Receives: Device: POLFA (Needle Assembly); Device: Kawasumi (Needle Assembly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following a one-time whole blood donation, samples were measured within 1 month of donation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transmission, Blood, Recipient/DonorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lou Ann Maes, MD, Principal investigator, American Red Cross Mid-Atlantic RegionJose Cancelas, MD, Principal investigator, Hoxworth Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476851
- Sponsor's protocol ID
- TP-CLN-100380
- Status last verified
- Apr 2022
- First submitted
- 11 Jun 2015
- Last updated
- 29 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
- ClinicalTrials.gov ID
- NCT02476851
- Acronym / sponsor ID
- TP-CLN-100380
- Conditions
- Transmission, Blood, Recipient/Donor
- Keywords
- Blood Donation, Whole Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 29 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly) | Other | Device: POLFA (Needle Assembly), Device: 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) | Other | Device: POLFA (Needle Assembly), Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POLFA (Needle Assembly)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. | Device | Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly), POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly) |
| Kawasumi (Needle Assembly)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. | Device | Kawasumi (Control Needle Assembly) first, then POLFA (Experimental Needle Assembly), POLFA (Experimental Needle Assembly) first, then Kawasumi (Control Needle Assembly) |
Primary outcome
Plasma Supernatant Hemoglobin
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Transmission, Blood, Recipient/Donor
Recruiting
HIV+ Deceased Donor Heart Transplant Study for HIV+ Recipients
HIV Infection, Advanced End Stage Heart Failure
RecruitingObservational study
Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors
Human Immunodeficiency Virus, End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lou Ann Maes, MD principal investigator
American Red Cross Mid-Atlantic Region
Jose Cancelas, MD principal investigator
Hoxworth Blood Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POLFA (Needle Assembly) and Kawasumi (Needle Assembly) in people with Transmission, Blood, Recipient/Donor, run by Haemonetics Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Supernatant Hemoglobin (time frame: Following a one-time whole blood donation, samples were measured within 1 month of donation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.