PFA 100 Evaluation and Reference Interval HOACNY

• Sponsor: Hematology Oncology Associates of Central New York (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06100510
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Effect of Drug	Drug: Aspirin 325mg	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: PFA 100 Evaluation and Reference Interval HOACNY
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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] [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] [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hematology Oncology Associates of Central New York

Investigators

• Principal Investigator: Theresa O'Sullivan, BS,MLT(ASCP), Employee
• Study Director: Steven Duffy, MD, Physician

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hematology Oncology Associates of Central New York
• ClinicalTrials.gov Identifier: NCT06100510
• Other Study ID Numbers: HOACNYPFA100.001
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Aspirin

Study Results

No Results Posted as of Oct 25, 2023