Effect of Drug
Conditions
Brief summary
The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.
Interventions
DRUGAspirin 325mg
Cohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw.
Sponsors
Hematology Oncology Associates of Central New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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] | 3 months | 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). |
| 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] | 3 months | 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. |
Countries
United States
Outcome results
None listed