PFA 100 Evaluation and Reference Interval HOACNY

NCT06100510 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: HOACNYPFA100.001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Placebo (non-intervention) Arm

NO INTERVENTION

Participants who will have PFA 100 testing performed without the ingestion of aspirin.

Aspirin Arm

ACTIVE COMPARATOR

Participants who will have PFA 100 testing performed after the ingestion of aspirin.

Drug: Aspirin 325mg

Interventions

Aspirin 325mg DRUG

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

Aspirin Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able to consent to study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hematology Oncology Associates of Central New York: lead

Study Sites (1)

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Theresa O'Sullivan, BS,MLT(ASCP)

  Employee

  PRINCIPAL INVESTIGATOR

• Steven Duffy, MD

  Physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 25, 2023
• Study Start: February 19, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)