[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584980":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Tallaght University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PuraStat® combined with Adrenaline","EXPERIMENTAL","In this experimental arm PuraStat® (mL) will be administered in combination with an injection of Adrenaline (mL).",[13],"Combination Product: PuraStat® combined with Adrenaline",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","This arm will be the active comparator, will include all types of standard of care currently recommended for the treatment of bleeding lesions, such as, adrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).",[19],"Combination Product: Standard of Care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","PuraStat® application (mL) combined with Adrenaline injection (mL)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Adrenaline injection + second hemostasis modality (contact thermal, mechanical therapy, or injection of a sclerosing agent).",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Raquel Ballester","CONTACT","973705342","rballester.lleida.ics@gencat.cat",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital Arnau de Vilanova de Lleida","RECRUITING","Lleida","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],0.62218,41.61674,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":25,"phoneExt":25,"email":25},"Raquel Ballester, MD",{"type":52,"investigatorFullName":31,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100584980","purastat-combined-with-adrenaline-versus-standard-of-care-in-upper-gastrointestinal-bleeding-100584980",false,"NCT06896409","PuraStat® Combined With Adrenaline Versus Standard of Care in Upper Gastrointestinal Bleeding","PuraStat® Combined With Adrenaline Versus Standard of Care in Non-variceal Upper Gastrointestinal Bleeding. Multicentric International Clinical Trial.","Inclusion Criteria:\n\n* Age \\>18 years\n* Undergoing endoscopic therapy for non-variceal gastrointestinal bleeding\n\nExclusion Criteria:\n\n* Variceal or portal hypertension-related gastrointestinal bleeding\n* Lack of signed consent form\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":64,"type":65},126,"ESTIMATED","INTERVENTIONAL",[68],"NA","PuraStat® is a novel gel that offers several advantages over traditional hemostatic powders. Its transparency allows for continuous visualization of the bleeding site, and it can be applied in narrow spaces or in combination with other treatments. Additionally, the pre-filled syringe design ensures ease of handling and precise delivery.\n\nMost published data on PuraStat® as a hemostatic agent originates from surgical settings. In endoscopy, its primary applications have been in polypectomy-related hemostasis and the promotion of wound healing. Reports indicate a hemostasis success rate of 90.4%, with a recurrence rate of 10.4%.\n\nLimited data exist regarding the efficacy of PuraStat® as a hemostatic agent in upper gastrointestinal bleeding (UGIB) lesions. This study hypothesizes that PuraStat®, when combined with Adrenaline, serves as a feasible and effective first-line treatment for gastrointestinal bleeding. To evaluate this, a prospective, randomized, parallel-group, open-label clinical trial is proposed.",[71],"Upper Gastrointestinal Bleeding","2025-03-25",{"date":74,"type":75},"2025-03-26","ACTUAL",{"date":77,"type":75},"2023-10-01",{"date":79,"type":65},"2025-10",{"name":5,"class":6},1]