[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibrinolysis-hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibrinolysis-hemorrhage":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,65,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878",false,"NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"ALL","0 Years","20 Years",{"count":22,"type":23},5000,"ESTIMATED","OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","RECRUITING","2026-03-31",{"date":55,"type":56},"2026-04-06","ACTUAL",{"date":58,"type":56},"2020-03-05",{"date":60,"type":23},"2027-07",{"name":62,"class":63},"Duke University","OTHER",51,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":18,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100605575","comparative-study-of-tranexamic-acid-dosing-in-cardiac-surgery-100605575","NCT07164300","Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery","Comparative Study of Tranexamic Acid Dosage Regimens in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Patients undergoing elective cardiac surgery using cardiopulmonary bypass\n* Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.\n\nExclusion Criteria:\n\n* Age below 18 years\n* Patient refusal\n* Pregnancy\n* End-stage renal disease\n* History of epilepsy,\n* Cardiac surgery without the use of cardiopulmonary bypass (off-pump)\n* Emergency operations\n* Known allergy to the administered agents.","18 Years","99 Years",{"count":75,"type":23},150,"INTERVENTIONAL",[78],"NA","Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion. However, there is no consensus regarding the dosage regimen of tranexamic acid that should be administered. The purpose of this study is to compare different dosages of tranexamic acid in cardiac surgery using cardiopulmonary bypass regarding the duration of inhibition of fibrinolysis as measured by the ClotPro test.\n\nBlood samples will be taken from the arterial line placed in the patient at specified time points in order to perform viscoelastic tests (ClotPro, TPA test), to detect successful inhibition of fibrinolysis and to measure tranexamic acid levels in the patient's blood. In case the action of tranexamic acid stops early postoperatively an additional dose of the medication will be administered to the patient.",[81,82,83,46,84],"Blood Coagulation Disorder","Postoperative Blood Loss","Adverse Drug Event","Tranexamic Acid Adverse Reaction","2025-09-05",{"date":87,"type":56},"2025-09-10",{"date":89,"type":56},"2024-05-14",{"date":91,"type":23},"2027-12-15",{"name":93,"class":63},"University of Ioannina",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":18,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":76,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":5},"100501214","goal-directed-vs-empirical-tranexamic-acid-administrationin-cardiovascular-surgery-100501214","NCT05806346","Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery","Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration","Inclusion Criteria:\n\n* patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass\n* patients who provide written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* refusal of allogenic blood transfusion\n* taking thrombin\n* history of thromboembolic and familial hypercoagulability disease\n* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)\n* hypersensitive to TXA\n* histroy of convulsion or epilepsy\n* taking hemodialysis\n* history of Heparin-induced thrombocytopenia","19 Years",{"count":104,"type":23},764,[78],"The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.\n\nThe study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.\n\nThe secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.\n\nResearchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.",[108,109,110,111,46],"Heart Diseases","Vascular Diseases","Transfusion Related Complication","Coagulation Disorder, Blood","2024-12-15",{"date":114,"type":56},"2024-12-18",{"date":116,"type":56},"2023-08-01",{"date":118,"type":23},"2025-06-30",{"name":120,"class":63},"Konkuk University Medical Center"]