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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: Aspirin 325mg

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hematology Oncology Associates of Central New York
• Investigators: Principal Investigator: Theresa O'Sullivan, BS,MLT(ASCP), employee; Study Director: Steven Duffy, MD, Physician

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): October 10, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: HOACNYPFA100.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes