[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571859":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous","EXPERIMENTAL",null,[13],"Drug: Tranexamic Acid",{"label":15,"type":10,"description":11,"interventionNames":16},"Nebulized",[17],"Drug: Tranexamic Acid (TXA)",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Tranexamic Acid (TXA)","To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery",[15],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Tranexamic Acid","To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery",[9],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Asmaa Shabaan Zanaty, Doctor","CONTACT","+201029505921","asmaa10557@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Main building, Assiut University Hospitals","RECRUITING","Asyut","Egypt","EG",{"type":42,"coordinates":43},"Point",[44,45],31.18368,27.18096,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":32,"phoneExt":11,"email":33},"Asmaa Shabaan",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Asmaa Zanaty","Assistant Lecturer","100571859","early-phase-1-assessment-of-nebulized-tranexamic-acid-in-functional-endoscopic-sinus-surgery-using-modena-bleeding-score-100571859",false,"NCT06725732","Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score","Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. A Randomized Double Blinded Controlled Trial.","Inclusion Criteria:\n\n1. Either sex\n2. age 18-65 years\n3. ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia\n4. normal accepted coagulation profile and hematocrit value ≥30\n\nExclusion Criteria:\n\n* • chronic renal failure\n\n  * liver cirrhosis\n  * bleeding disorders\n  * current anticoagulant therapy\n  * pregnancy or breastfeeding\n  * impaired color vision\n  * severe vascular ischemia\n  * history of venous thrombosis, pulmonary embolism\n  * long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery\n  * hemoglobin (HB) concentration \\\u003C10 mg\u002Fdl \\_allergy to TXA.\n  * BMI \\> 35 kg\u002F m2",true,"ALL","18 Years","65 Years",{"count":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"EARLY_PHASE1","The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.\n\nPrimary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome\n\n1. Patient hemodynamics.\n2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane\\>2\n3. Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.",[73],"Blood Loss, Surgical","2025-01-27",{"date":76,"type":77},"2025-01-29","ACTUAL",{"date":76,"type":67},{"date":80,"type":67},"2026-01-01",{"name":5,"class":6},1]