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Enrolling by Invitation

NCT Number: NCT06100510

PFA 100 Evaluation and Reference Interval HOACNY

The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.

Enrolling by Invitation

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 325mg

Drug

Cohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw.

Primary outcomes

  1. 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]

    Time frame: 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).

  2. 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]

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hematology Oncology Associates of Central New York

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2023
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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