PFA 100 Evaluation and Reference Interval HOACNY

Study Overview
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Brief Summary
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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.

Official Title
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PFA 100 Evaluation and Reference Interval HOACNY

Conditions
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Effect of Drug

Intervention / Treatment
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* Drug: Aspirin 325mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Able to consent to study Exclusion Criteria from entire study Primary hemostasis diagnosis Von Willebrand Disease Bernard-Soulier syndrome Glanzmann thrombasthenia Idiopathic thrombocytopenic purpura Drug-induced thrombocytopenia Heparin-induced thrombocytopenia Thrombotic thrombocytopenic purpura Hemolytic uremic syndrome Participant is on anticoagulant therapy Specifically thienopyrdines [Ticlopidine, Clopidogrel] and GPIIb/IIIa inhibitors [ReoPro, Aggrastat, Integrilin] 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 Potential for adverse reactions between current medication and aspirin as dictated by staff pharmacist Allergy to ASA or aspirin Previous allergic reaction to ASA or aspirin Participant is pregnant Asthma, or history of, with nasal polyps and rhinitis Stomach ulcers or bleeding Severe kidney disease Severe liver disease Hemophilia Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo (non-intervention) Arm<br>Participants who will have PFA 100 testing performed without the ingestion of aspirin. | |
| Active Comparator: Aspirin Arm<br>Participants who will have PFA 100 testing performed after the ingestion of aspirin. | Drug: Aspirin 325mg<br>* Cohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |