Back to search results
NCT06100510

PFA 100 Evaluation and Reference Interval HOACNY

Enrolling by Invitation
PHASE4Ages 18+InterventionalScreening
Hematology Oncology Associates of Central New York
~40 participants
Updated 2024-10-03 on ClinicalTrials.gov
What's tested:Aspirin 325mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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]
Measured over 3 months
+1 more outcome measured

Conditions

Effect of Drug

Explore related trials

Healthy Subjects

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Theresa O'Sullivan, BS,MLT(ASCP) · PRINCIPAL_INVESTIGATOR · Employee
  • Steven Duffy, MD · STUDY_DIRECTOR · Physician

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age 18 years or older
Able to consent to study

Exclusion

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
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

What this trial measures

  • 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.