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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lou Ann Maes, MD | American Red Cross Mid-Atlantic Region | Principal Investigator |
| Jose Cancelas, MD | Hoxworth Blood Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemonetics | Braintree | Massachusetts | 02184 | United States | ||
| Hoxworth Blood Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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| Cincinnati |
| Ohio |
| 45267 |
| United States |
| American Red Cross Mid-Atlantic Region Blood Services | Norfolk | Virginia | 23507 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Temperature | Mean | Standard Deviation | degrees F |
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| Weight | Mean | Standard Deviation | pounds |
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| Height | Mean | Standard Deviation | inches |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Pulse | Mean | Standard Deviation | bpm |
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| Donor Hemoglobin | Mean | Standard Deviation | g/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants analyzed represents all participants that contributed blood to each assembly. | Posted | Mean | Standard Deviation | mg/dL | Following a one-time whole blood donation, samples were measured within 1 month of donation. |
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Up to 24 hours following the end of study procedure (one-time whole blood donation).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POLFA (Experimental Needle Assembly) | Blood was drawn through the experimental assembly and the hemoglobin levels were measured. | 0 | 60 | 0 | 60 | 0 | 60 |
| EG001 | Kawasumi (Control Needle Assembly) | Blood was drawn through the Control assembly and the hemoglobin levels were measured. | 0 | 60 | 0 | 60 | 0 | 60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Hartmann, MD | Haemonetics Corporation | (781) 348 7396 | Jan.Hartmann@haemonetics.com |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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