[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06100510":3,"trial-entities:NCT06100510":102,"trial-summary:NCT06100510":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":14,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":78,"locations":81,"central_contacts":90,"overall_officials":91,"references":100,"see_also_links":101},"NCT06100510","HOACNYPFA100.001","PFA 100 Evaluation and Reference Interval HOACNY","ENROLLING_BY_INVITATION","2024-10-10","2024-10","2024-10-03","2024-02-19","Hematology Oncology Associates of Central New York","OTHER",null,"The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.",[17],"Effect of Drug",[],"INTERVENTIONAL","SCREENING",[22],"PHASE4",{"count":24,"type":25},40,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DRUG","Aspirin 325mg","Cohort B will receive one (1) 325 mg aspirin 24 hours prior to their second blood draw.",[32],"Aspirin Arm",[34,38],{"measure":35,"description":36,"timeFrame":37},"Instrument Evaluation Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen\u002Fepinephrine (COL\u002FEPI) cartridges and collagen\u002FADP (COL\u002FADP) cartridges]","This portion of the study is to ensure that the functionality of the instrumentation is working properly.\n\nFor each participant, their pre-aspirin dose closure times will be compared to their post-aspirin dose closure times.\n\nThe 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\u002FEPI and COL\u002FADP cartridges (normal).\n\nIn general, the pattern seen after aspirin ingestion is a CT result outside the reference range (abnormal) with COL\u002FEPI and within the reference range for COL\u002FADP (normal).","3 months",{"measure":39,"description":40,"timeFrame":37},"Reference Interval Protocol-PFA100 Instrumentation [platelet function as measured by aperture closure time monitored in seconds for collagen\u002Fepinephrine (COL\u002FEPI) cartridges and collagen\u002FADP (COL\u002FADP) cartridges]","For each participant in the non-intervention\u002Fplacebo arm, platelet function as measured by aperture closure time monitored in seconds for collagen\u002Fepinephrine (COL\u002FEPI) cartridges and collagen\u002FADP (COL\u002FADP) cartridges will be captured.\n\nFollowing guidelines as stated per CLSI document EP28-A3c, a reference interval will be developed from this captured data.",[],"ALL","18 Years",true,{"inclusion":46,"exclusion":49,"raw_text":77},[47,48],"Age 18 years or older","Able to consent to study",[50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"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\u002FIIIa 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\u002FuL","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","Inclusion Criteria:\n\n* Age 18 years or older\n* Able to consent to study\n\nExclusion Criteria from entire study\n\n* Primary hemostasis diagnosis\n\n  * Von Willebrand Disease\n  * Bernard-Soulier syndrome\n  * Glanzmann thrombasthenia\n  * Idiopathic thrombocytopenic purpura\n  * Drug-induced thrombocytopenia\n  * Heparin-induced thrombocytopenia\n  * Thrombotic thrombocytopenic purpura\n  * Hemolytic uremic syndrome\n* Participant is on anticoagulant therapy\n\n  * Specifically thienopyrdines \\[Ticlopidine, Clopidogrel\\] and GPIIb\u002FIIIa inhibitors \\[ReoPro, Aggrastat, Integrilin\\]\n* Participant is on medication that contains ASA or aspirin (see list below in Study Procedure)\n* Participant is on nonsteroidal anti-inflammatory agents that are known to induce temporary platelet dysfunction (see list below in Study Procedure)\n* Participant is on non-prescription medications containing aspirin (see list below in Study Procedure)\n* 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)\n* If hematocrit is less than 35%\n* If platelets are less than 150 x10\\^3\u002FuL\n\nExclusion Criteria from Cohort B but not Cohort A\n\n* Potential for adverse reactions between current medication and aspirin as dictated by staff pharmacist\n* Allergy to ASA or aspirin\n* Previous allergic reaction to ASA or aspirin\n* Participant is pregnant\n* Asthma, or history of, with nasal polyps and rhinitis\n* Stomach ulcers or bleeding\n* Severe kidney disease\n* Severe liver disease\n* Hemophilia\n* Pregnant or breast feeding",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":12,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"East Syracuse","New York","13057","United States",{"lat":88,"lon":89},43.06534,-76.07853,[],[92,96],{"name":93,"affiliation":94,"role":95},"Theresa O'Sullivan, BS,MLT(ASCP)","Employee","PRINCIPAL_INVESTIGATOR",{"name":97,"affiliation":98,"role":99},"Steven Duffy, MD","Physician","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Healthy Subjects",[],{"nct_id":4,"found":107,"summary":14,"prompt_version":14},false]