[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583845":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":69,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tranexamic acid and vitamin K","EXPERIMENTAL","97 cirrhotic patients presenting with UGIB receiving tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24-48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.",[13],"Drug: Tranexamic Acid and vitamin K",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","97 cirrhotic patients presenting with UGIB receiving IV saline besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tranexamic Acid and vitamin K","Tranxemic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection (10 mg daily of vitamin K for 24-48 h) along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients.\n\nPatients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Intravenous saline over 24-48 hours along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients.\n\nPatients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.",[15],[31],{"name":32,"affiliation":33,"role":34},"Rania M Elkafoury, MD","Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+201004672358","rania.elkafoury@med.tanta.edu.eg",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Mennat-Allah M El Sawaf, MD","00201225548976","mennaallah.elsawaf@med.tanta.edu.eg",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Tanta University Hospitals","RECRUITING","Tanta","Gharbyea","31516","Egypt","EG",{"type":54,"coordinates":55},"Point",[56,57],31.00192,30.78847,{"lat":57,"lon":56},[60,64,65,68],{"name":61,"role":37,"phone":62,"phoneExt":26,"email":63},"Dina H Ziada, MD","00201117109990","dina.ziada@med.tanta.edu.eg",{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":66,"role":67,"phone":26,"phoneExt":26,"email":26},"Nabila A Elgazzar, MD","SUB_INVESTIGATOR",{"name":41,"role":67,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Rania Mamdouh Elkafoury","Lecturer of Tropical Medicine","100583845","phase-4-tranxemic-acid-and-vitamin-k-injection-to-control-upper-gastrointestinal-bleeding-in-cirrhotic-patients-100583845",false,"NCT06881628","Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients","Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Liver cirrhosis\n* Upper gastrointestinal bleeding\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Allergy to tranexamic acid\n* Allergy to vitamin K injection\n* DIC.\n* Thromboembolic event.\n* Pregnancy or lactation.\n* End-stage renal disease.\n* Unwilling to participate in our study.","ALL","18 Years",{"count":82,"type":83},194,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.\n\nResearchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.\n\nParticipants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.\n\nFollow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.\n\nThe rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.\n\nAt discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.\n\nSecond follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.",[89,90,91],"Upper Gastrointestinal Bleeding (UGIB)","Variceal Bleeding","Cirrhosis",[93,9,94],"Variceal bleeding","Liver cirrhosis","2025-03-11",{"date":97,"type":98},"2025-03-18","ACTUAL",{"date":100,"type":98},"2024-12-02",{"date":102,"type":83},"2025-12-30",{"name":5,"class":6},1]