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PFA 100 Evaluation and Reference Interval HOACNY

Phase 4

Waitlist Available

Led By Theresa O'Sullivan, BS,MLT(ASCP)

Research Sponsored by Hematology Oncology Associates of Central New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Participant is on non-prescription medications containing aspirin

Asthma, or history of, with nasal polyps and rhinitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test how well a new instrument works and gather data from healthy volunteers to establish what is considered normal. "This trial evaluates a new instrument's performance and collects data from healthy volunteers to

Who is the study for?

This clinical trial is open to adults aged 18 or older who can give consent to participate. It's designed for healthy volunteers who want to help establish normal reference ranges for a new medical instrument.

What is being tested?

The study is testing the effects of a single dose of Aspirin (325mg) on participants. The goal is to evaluate how well a new medical instrument works and develop normal data ranges based on the responses from these healthy individuals.

What are the potential side effects?

Aspirin may cause side effects such as stomach pain, heartburn, nausea, gastrointestinal bleeding, allergic reactions, and increased risk of bruising or bleeding in some people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking over-the-counter aspirin.

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I have asthma, nasal polyps, and rhinitis.

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I have stomach ulcers or bleeding.

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I have a diagnosed blood clotting disorder.

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I am currently taking medication that contains aspirin.

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I am taking medication that affects my blood's ability to clot.

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I am currently taking blood thinners like Ticlopidine or Clopidogrel.

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I have severe kidney disease.

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I have severe liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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]

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]