An interventional study of POLFA (Needle Assembly) and Kawasumi (Needle Assembly) in Transmission, Blood, Recipient/Donor, sponsored by Haemonetics Corporation. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Haemonetics Corporation · Not applicable, Interventional, and Other
This study evaluates whether whole blood transferred through the new POLFA needle assembly meets supernatant hemoglobin acceptability standards.
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.
Haemonetics Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligibility Criteria:
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.).
Exclusion Criteria - any individual not meeting the above criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · 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.
Device: POLFA (Needle Assembly) · Device: 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.
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.
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.
Time frame: Following a one-time whole blood donation, samples were measured within 1 month of donation.
| Milestone | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly) |
|---|---|---|
| Started | 31 | 31 |
| Completed | 30 | 30 |
| Not completed | 1 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
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.
| mg/dL | POLFA (Experimental Needle Assembly) | Kawasumi (Control Needle Assembly) |
|---|---|---|
| Plasma Supernatant Hemoglobin | 26.8 ± 15.7 | 28.0 ± 14.6 |
Collected over Up to 24 hours following the end of study procedure (one-time whole blood donation).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| POLFA (Experimental Needle Assembly) | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Kawasumi (Control Needle Assembly) | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| Mean | 46.3 ± 13.4 | 47.1 ± 12.5 | 46.7 ± 12.8 |
| Sex: Female, Male(Participants) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| Female | 19 | 15 | 34 |
| Male | 12 | 16 | 28 |
| Ethnicity (NIH/OMB)(Participants) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 31 | 31 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 26 | 27 | 53 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| United States | 31 | 31 | 62 |
| Body Temperature(degrees F) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| Mean | 98.0 ± 0.57 | 97.8 ± 0.55 | 97.9 ± 0.57 |
| Weight(pounds) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| Mean | 172.3 ± 33.5 | 186.4 ± 38.9 | 179.4 ± 36.7 |
| Height(inches) | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly | Total |
|---|---|---|---|
| Mean | 66.2 ± 3.7 | 67.1 ± 3.5 | 66.7 ± 3.6 |
4 further baseline measures are reported on the registry.
The record gives a start of Jun 2015, a primary completion of Jul 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2022, 6 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Haemonetics Corporation