[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536867":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":60,"collaborators":62,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":32,"enrollmentInfo":99,"targetDuration":32,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"St. Olavs Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tranexamic acid arm","ACTIVE_COMPARATOR","Anonymous ampoule containing 5 ml of 100 mg\u002Fml Tranexamic Acid. If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.",[13],"Drug: Tranexamic Acid 100 MG\u002FML",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","Anonymous ampoule containing 5 ml of 0.9% NaCl. If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.",[19],"Drug: 0.9%sodium chloride",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tranexamic Acid 100 MG\u002FML","If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using tranexamic acid",[9],[27],"Saline (placebo)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"0.9%sodium chloride","If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Kjersti Ausen, MD PhD","St Olav's University Hospital","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","+4792249693","kjerstiausen@gmail.com",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Olav Spigset, MD PhD","+47 936 64 337","olav.spigset@legemidler.no",[48],{"facility":36,"status":49,"city":50,"state":32,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":32},"RECRUITING","Trondheim","7006","Norway","NO",{"type":55,"coordinates":56},"Point",[57,58],10.39506,63.43049,{"lat":58,"lon":57},{"type":61,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[63,65,67,69,72,74,76,78,80,82,84,87],{"name":64,"class":6},"Smerud Medical Research International AS",{"name":66,"class":6},"Sykehuset Asker og Baerum",{"name":68,"class":6},"Oslo University Hospital",{"name":70,"class":71},"Sykehuset Telemark","OTHER_GOV",{"name":73,"class":6},"Sykehuset Innlandet HF",{"name":75,"class":6},"Molde Hospital",{"name":77,"class":6},"Haukeland University Hospital",{"name":79,"class":6},"Haraldsplass Deaconess Hospital",{"name":81,"class":71},"Helse Stavanger HF",{"name":83,"class":6},"University Hospital of North Norway",{"name":85,"class":86},"Bodø sykehus","UNKNOWN",{"name":88,"class":6},"Helsinki University Central Hospital","100536867","phase-4-the-effect-of-local-application-of-tranexamic-acid-versus-placebo-on-postoperative-complications-in-plastic-surgery-100536867",false,"NCT06270407","The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery","The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery - A Multicenter Randomized Controlled Trial","TRANOP","Inclusion Criteria:\n\n* Patients are eligible to be included in the study only if all of the following criteria apply:\n\n  1. They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.\n  2. They are over 18 years of age and capable of independently providing informed consent\n  3. They have received adequate oral and written information about the study and signed the informed-consent form\n\nExclusion Criteria:\n\n* Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English.","ALL","18 Years",{"count":100,"type":101},3000,"ESTIMATED","INTERVENTIONAL",[104],"PHASE4","Study objective:\n\nThis is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.\n\nEligible patients:\n\nPatients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.\n\nStudy intervention:\n\nParticipants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.",[107],"Surgical Complication",[109],"tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism","2024-12-02",{"date":112,"type":113},"2024-12-04","ACTUAL",{"date":115,"type":113},"2024-10-01",{"date":117,"type":101},"2029-12-31",{"name":5,"class":6},1]