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The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (non-intervention) Arm | No Intervention | Participants who will have PFA 100 testing performed without the ingestion of aspirin. | |
| Aspirin Arm | Active Comparator | Participants who will have PFA 100 testing performed after the ingestion of aspirin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 325mg | Drug | Cohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Instrument Evaluation Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges] | This portion of the study is to ensure that the functionality of the instrumentation is working properly. For each participant, their pre-aspirin dose closure times will be compared to their post-aspirin dose closure times. The typical pattern seen in subjects with normal platelet function (pre-aspirin testing) is closure time (CT) results within the reference range for both the COL/EPI and COL/ADP cartridges (normal). In general, the pattern seen after aspirin ingestion is a CT result outside the reference range (abnormal) with COL/EPI and within the reference range for COL/ADP (normal). | 3 months |
| Reference Interval Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges] | For each participant in the non-intervention/placebo arm, platelet function as measured by aperture closure time monitored in seconds for collagen/epinephrine (COL/EPI) cartridges and collagen/ADP (COL/ADP) cartridges will be captured. Following guidelines as stated per CLSI document EP28-A3c, a reference interval will be developed from this captured data. | 3 months |
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Inclusion Criteria:
Exclusion Criteria from entire study
Primary hemostasis diagnosis
Participant is on anticoagulant therapy
Participant is on medication that contains ASA or aspirin (see list below in Study Procedure)
Participant is on nonsteroidal anti-inflammatory agents that are known to induce temporary platelet dysfunction (see list below in Study Procedure)
Participant is on non-prescription medications containing aspirin (see list below in Study Procedure)
PFA-100 result falls outside of reference interval listed in the package insert (suggested criteria in the PFA-100 Evaluation Protocol as described in the PFA-100 System: Getting Started Guide)
If hematocrit is less than 35%
If platelets are less than 150 x10^3/uL
Exclusion Criteria from Cohort B but not Cohort A
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| Name | Affiliation | Role |
|---|---|---|
| Theresa O'Sullivan, BS,MLT(ASCP) | Employee | Principal Investigator |
| Steven Duffy, MD | Physician | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
IPD will not be shared with other researchers.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2024 | Oct 29, 2024 | 3 | ||
| Nov 1, 2024 |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Nov 27, 2024 |
| 4 |
| Sep 8, 2025 | Sep 26, 2025 | 5 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |