[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Perosphere Technologies Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100593888","clinical-performance-evaluation-of-native-whole-blood-samples-of-patients-on-doacs-with-the-perosphere-clotchek-100593888",false,"NCT07012291","Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™","Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants (DOACs) With the Perosphere ClotChek™ Coagulometer","Inclusion Criteria:\n\n* Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.\n* Be 18- to 80-years-of-age, inclusive, at time of consent.\n* Have suitable venous access for at least a single venipuncture.\n* Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion\n* Eligible patients on anticoagulants must have been on their anticoagulant therapy for at least one month.\n\nExclusion Criteria:\n\n* Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions, other than the condition for which a DOAC was prescribed.\n* Have a history of unexplained syncope.\n* Have a history within six months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).\n* Consume more than five cigarettes per day.\n* If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).\n* If female, be pregnant, breastfeeding, or planning to become pregnant during the study.","ALL","18 Years","80 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC). The instrument performs a whole blood clotting time (WBCT) test using freshly drawn, non-citrated whole blood. The purpose of the present study is to characterize the performance of the Perosphere ClotChek™ as a quantitative measurement of the WBCT in patients taking one of the following Direct Oral Anticoagulants (DOACs), rivaroxaban or apixaban.",[25],"Coagulation","RECRUITING","2025-09-09",{"date":29,"type":30},"2025-09-16","ACTUAL",{"date":32,"type":30},"2025-06-20",{"date":34,"type":21},"2027-06-01",{"name":36,"class":37},"Perosphere Technologies Inc.","INDUSTRY",4,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":46,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100560854","evaluation-of-clinical-ranges-of-whole-blood-clotting-times-of-patients-on-anticoagulants-100560854","NCT06582563","Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants","Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times","Inclusion Criteria:\n\n* In general, study participants must:\n\n  1. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.\n  2. Be 18- to 80-years-of-age, inclusive, at time of consent.\n  3. Have suitable venous access for at least a single venipuncture.\n  4. Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion\n\nExclusion Criteria:\n\n* Eligible patients on anticoagulants must not:\n\n  1. Other than the condition for which a DOAC was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.\n  2. Have a BMI\\> 40 or weight \\> 120kg.\n  3. Suffer from renal or hepatic insufficiency.\n  4. Suffer from any pathology that would contra-indicate in general DOAC medication.\n  5. Have a history of unexplained syncope.\n  6. Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).\n  7. Consume more than 5 cigarettes per day.\n  8. If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).\n  9. If female is pregnant, breastfeeding, or planning to become pregnant during study",{"count":47,"type":21},120,"Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).",[50],"Blood Coagulation Disorder","NOT_YET_RECRUITING","2024-10-03",{"date":54,"type":30},"2024-10-08",{"date":56,"type":21},"2025-03-01",{"date":58,"type":21},"2025-08-30",{"name":36,"class":37},1,""]