Transmission, Blood, Recipient/Donor
Conditions
Keywords
Blood Donation, Whole Blood
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.
Interventions
DEVICEPOLFA (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.
DEVICEKawasumi (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.
Sponsors
Haemonetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) Donors in this arm were randomized to have approximately half of their blood collection pass first through the POLFA Needle Assembly, and then through the Kawasumi Needle Assembly. | 31 |
| Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly Donors in this arm were randomized to have approximately half of their blood collection pass first through the Kawasumi Needle Assembly, and then through the POLFA Needle Assembly. | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly) | Total | Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 13.4 | 46.7 years STANDARD_DEVIATION 12.8 | 47.1 years STANDARD_DEVIATION 12.5 |
| Body Temperature | 98.0 degrees F STANDARD_DEVIATION 0.57 | 97.9 degrees F STANDARD_DEVIATION 0.57 | 97.8 degrees F STANDARD_DEVIATION 0.55 |
| Diastolic Blood Pressure | 74.6 mmHg STANDARD_DEVIATION 10.5 | 74.0 mmHg STANDARD_DEVIATION 10.1 | 73.3 mmHg STANDARD_DEVIATION 9.89 |
| Donor Hemoglobin | 14.2 g/dL STANDARD_DEVIATION 1.4 | 14.3 g/dL STANDARD_DEVIATION 1.3 | 14.4 g/dL STANDARD_DEVIATION 1.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 62 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 66.2 inches STANDARD_DEVIATION 3.7 | 66.7 inches STANDARD_DEVIATION 3.6 | 67.1 inches STANDARD_DEVIATION 3.5 |
| Pulse | 74.3 bpm STANDARD_DEVIATION 10.3 | 74.5 bpm STANDARD_DEVIATION 10.1 | 74.7 bpm STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 53 Participants | 27 Participants |
| Region of Enrollment United States | 31 participants | 62 participants | 31 participants |
| Sex: Female, Male Female | 19 Participants | 34 Participants | 15 Participants |
| Sex: Female, Male Male | 12 Participants | 28 Participants | 16 Participants |
| Systolic Blood Pressure | 128.4 mmHg STANDARD_DEVIATION 20.1 | 126.2 mmHg STANDARD_DEVIATION 18.98 | 124.0 mmHg STANDARD_DEVIATION 17.8 |
| Weight | 172.3 pounds STANDARD_DEVIATION 33.5 | 179.4 pounds STANDARD_DEVIATION 36.7 | 186.4 pounds STANDARD_DEVIATION 38.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
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.
Population: Number of participants analyzed represents all participants that contributed blood to each assembly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POLFA (Experimental Needle Assembly) | Plasma Supernatant Hemoglobin | 26.8 mg/dL | Standard Deviation 15.7 |
| Kawasumi (Control Needle Assembly) | Plasma Supernatant Hemoglobin | 28.0 mg/dL | Standard Deviation 14.6 |