PFA 100 Evaluation and Reference Interval HOACNY

Effect of Drug Clinical Trial

Official title:

PFA 100 Evaluation and Reference Interval HOACNY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100510
• Other study ID #: HOACNYPFA100.001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2023
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: Hematology Oncology Associates of Central New York
• Contact: Eric A Walradth, MA,MLS(ASCP)
• Phone: (315) 472-7504
• Email: ewalradth[@]hoacny.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Effect of Drug

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hematology Oncology Associates of Central New York

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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