Clinical trial NCT06100510: PFA 100 Evaluation and Reference Interval HOACNY
Official title: PFA 100 Evaluation and Reference Interval HOACNY
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Effect of Drug
Lead sponsor: Hematology Oncology Associates of Central New York
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility criteria: 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

Primary outcomes:
measure: 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]
timeFrame: 3 months
measure: 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]
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
Study officials:
affiliation: Employee
name: Theresa O'Sullivan, BS,MLT(ASCP)
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician
name: Steven Duffy, MD
role: STUDY_DIRECTOR
References: