PFA 100 Evaluation and Reference Interval HOACNY

Phase 4

• Conditions: Effect of Drug
• Interventions: Drug: Aspirin 325mg

• Registration Number: NCT06100510
• Lead Sponsor: Hematology Oncology Associates of Central New York

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Study Start: 2024-02-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin Arm	Aspirin 325mg	Participants who will have PFA 100 testing performed after the ingestion of aspirin.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hematology Oncology Associates of Central New York; 🇺🇸 East Syracuse, New York, United States