Trial Outcomes & Findings for Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder (NCT NCT02476851)
NCT ID: NCT02476851
Last Updated: 2022-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Following a one-time whole blood donation, samples were measured within 1 month of donation.
Results posted on
2022-04-29
Participant Flow
Participant milestones
| Measure |
POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control 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)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control 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)
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder
Baseline characteristics by cohort
| Measure |
POLFA (Experimental Needle Assembly) First, Then Kawasumi (Control Needle Assembly)
n=31 Participants
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.
|
Kawasumi (Control Needle Assembly) First, Then POLFA (Experimental Needle Assembly
n=31 Participants
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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Body Temperature
|
98.0 degrees F
STANDARD_DEVIATION 0.57 • n=5 Participants
|
97.8 degrees F
STANDARD_DEVIATION 0.55 • n=7 Participants
|
97.9 degrees F
STANDARD_DEVIATION 0.57 • n=5 Participants
|
|
Weight
|
172.3 pounds
STANDARD_DEVIATION 33.5 • n=5 Participants
|
186.4 pounds
STANDARD_DEVIATION 38.9 • n=7 Participants
|
179.4 pounds
STANDARD_DEVIATION 36.7 • n=5 Participants
|
|
Height
|
66.2 inches
STANDARD_DEVIATION 3.7 • n=5 Participants
|
67.1 inches
STANDARD_DEVIATION 3.5 • n=7 Participants
|
66.7 inches
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Systolic Blood Pressure
|
128.4 mmHg
STANDARD_DEVIATION 20.1 • n=5 Participants
|
124.0 mmHg
STANDARD_DEVIATION 17.8 • n=7 Participants
|
126.2 mmHg
STANDARD_DEVIATION 18.98 • n=5 Participants
|
|
Diastolic Blood Pressure
|
74.6 mmHg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
73.3 mmHg
STANDARD_DEVIATION 9.89 • n=7 Participants
|
74.0 mmHg
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Pulse
|
74.3 bpm
STANDARD_DEVIATION 10.3 • n=5 Participants
|
74.7 bpm
STANDARD_DEVIATION 10.0 • n=7 Participants
|
74.5 bpm
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Donor Hemoglobin
|
14.2 g/dL
STANDARD_DEVIATION 1.4 • n=5 Participants
|
14.4 g/dL
STANDARD_DEVIATION 1.1 • n=7 Participants
|
14.3 g/dL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
POLFA (Experimental Needle Assembly)
n=60 Participants
Blood was drawn through the experimental assembly and the hemoglobin levels were measured.
|
Kawasumi (Control Needle Assembly)
n=60 Participants
Blood was drawn through the control assembly and the hemoglobin levels were measured.
|
|---|---|---|
|
Plasma Supernatant Hemoglobin
|
26.8 mg/dL
Standard Deviation 15.7
|
28.0 mg/dL
Standard Deviation 14.6
|
Adverse Events
POLFA (Experimental Needle Assembly)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Kawasumi (Control Needle Assembly)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place