Status:
ENROLLING_BY_INVITATION
PFA 100 Evaluation and Reference Interval HOACNY
Lead Sponsor:
Hematology Oncology Associates of Central New York
Conditions:
Effect of Drug
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
- 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
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06100510
Start Date
February 19 2024
End Date
October 10 2024
Last Update
October 3 2024
Active Locations (1)
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1
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057