[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553123":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":56,"locations":65,"responsibleParty":184,"collaborators":188,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":200,"maxAge":18,"enrollmentInfo":201,"targetDuration":18,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":214,"overallStatus":85,"whyStopped":18,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fibrogammin (FXIII)","EXPERIMENTAL","Women in the intervention group receive FXIII intravenously in addition to the standard of care treatment for PPH. FXIII is administered when blood loss is \\> 700 ml. Women weighing \\\u003C80 kg receive 1250 IU Fibrogammin®; women weighing 80-99.9 kg receive 1500 IU Fibrogammin®; thus ensuring a dose of 15-20 IU FXIII per kg body weight according to the manufacturer's recommendation.",[13],"Drug: Fibrogammin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Women in the control group will be treat according to the standard of care procedure for PPH.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Fibrogammin","Fibrogammin is administered according to the Summary of product characteristics (SmPC) after measured blood loss exceeds 700 ml and bleeding is ongoing",[9],[26],"Factor XIII",[28,31,35,38,41,44,47,50,53],{"name":29,"affiliation":5,"role":30},"Christian Haslinger, Prof. Dr.","STUDY_CHAIR",{"name":32,"affiliation":33,"role":34},"Sara de Oliveira, MD","University Hospital, Geneva","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Hélène Legardeur, MD","University of Lausanne Hospitals",{"name":39,"affiliation":40,"role":34},"Beatrice Mosimann, Prof. Dr.","University Hospital, Basel, Switzerland",{"name":42,"affiliation":43,"role":34},"Tina Fischer, MD","HOCH Health Ostschweiz",{"name":45,"affiliation":46,"role":34},"Leonhard Schäffer, Prof. Dr.","Kantonsspital Baden",{"name":48,"affiliation":49,"role":34},"Michael Winter, MD","Spital Zollikerberg",{"name":51,"affiliation":52,"role":34},"Jarmila Zdanowicz, MD","Inselspital-University Hospital Bern",{"name":54,"affiliation":55,"role":34},"Leila Sultan-Beyer, MD","Cantonal Hospital Winterthur",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":18,"email":61},"Christian Haslinger, Prof. Dr","CONTACT","0041 432537575","Christian.haslinger@usz.ch",{"name":63,"role":59,"phone":18,"phoneExt":18,"email":64},"Annick Toggenburger, PhD","annick.toggenburger-schroeder@usz.ch",[66,84,97,108,120,132,144,156,172],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"University Hospital Geneva","NOT_YET_RECRUITING","Geneva","Canton of Geneva","1205","Switzerland","CH",{"type":75,"coordinates":76},"Point",[77,78],6.14569,46.20222,{"lat":78,"lon":77},[81],{"name":82,"role":59,"phone":18,"phoneExt":18,"email":83},"Begoña Martinez de Tejada, MD PhD","begona.martinezdetejada@hcuge.ch",{"facility":55,"status":85,"city":86,"state":87,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"RECRUITING","Winterthur","Canton of Zurich","8401",{"type":75,"coordinates":90},[91,92],8.72413,47.50564,{"lat":92,"lon":91},[95],{"name":54,"role":59,"phone":18,"phoneExt":18,"email":96},"leila.sultan-beyer@ksw.ch",{"facility":49,"status":85,"city":98,"state":87,"zip":99,"country":72,"countryCode":73,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Zollikerberg","8125",{"type":75,"coordinates":101},[102,103],8.60088,47.3451,{"lat":103,"lon":102},[106],{"name":48,"role":59,"phone":18,"phoneExt":18,"email":107},"michael.winter@spitalzollikerberg.ch",{"facility":109,"status":85,"city":110,"state":87,"zip":111,"country":72,"countryCode":73,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University Hospital of Zurich","Zurich","8091",{"type":75,"coordinates":113},[114,115],8.55,47.36667,{"lat":115,"lon":114},[118,119],{"name":29,"role":59,"phone":60,"phoneExt":18,"email":61},{"name":63,"role":59,"phone":18,"phoneExt":18,"email":64},{"facility":121,"status":85,"city":122,"state":18,"zip":123,"country":72,"countryCode":73,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Cantonal Hospital Baden","Baden","5404",{"type":75,"coordinates":125},[126,127],8.30592,47.47333,{"lat":127,"lon":126},[130],{"name":45,"role":59,"phone":18,"phoneExt":18,"email":131},"Leonhard.Schaeffer@ksb.ch",{"facility":133,"status":85,"city":134,"state":18,"zip":135,"country":72,"countryCode":73,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"University Hospital Basel","Basel","4031",{"type":75,"coordinates":137},[138,139],7.57327,47.55839,{"lat":139,"lon":138},[142],{"name":39,"role":59,"phone":18,"phoneExt":18,"email":143},"beatrice.mosimann@usb.ch",{"facility":52,"status":85,"city":145,"state":18,"zip":146,"country":72,"countryCode":73,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Bern","3010",{"type":75,"coordinates":148},[149,150],7.44744,46.94809,{"lat":150,"lon":149},[153],{"name":154,"role":59,"phone":18,"phoneExt":18,"email":155},"Jarmila Zdanowicz","jarmila.zdanowicz@insel.ch",{"facility":157,"status":85,"city":158,"state":18,"zip":159,"country":72,"countryCode":73,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University Hospital Lausanne","Lausanne","1005",{"type":75,"coordinates":161},[162,163],6.63282,46.516,{"lat":163,"lon":162},[166,169],{"name":167,"role":59,"phone":18,"phoneExt":18,"email":168},"David Baud, MD PhD","david.baud@chuv.ch",{"name":170,"role":59,"phone":18,"phoneExt":18,"email":171},"Helene Legardeur","helene.legardeur@chuv.ch",{"facility":173,"status":85,"city":174,"state":18,"zip":175,"country":72,"countryCode":73,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Cantonal Hospital St. Gallen","Sankt Gallen","9007",{"type":75,"coordinates":177},[178,179],9.37477,47.42391,{"lat":179,"lon":178},[182],{"name":42,"role":59,"phone":18,"phoneExt":18,"email":183},"tina.fischer@kssg.ch",{"type":185,"investigatorFullName":186,"investigatorTitle":187,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Christian Haslinger","Prof. Dr. med. Christian Haslinger",[189],{"name":190,"class":6},"Swiss National Science Foundation","100553123","phase-4-swift---swiss-factor-xiii-trial-in-pph-100553123",false,"NCT06481995","SWIFT - SWIss Factor XIII Trial in PPH","Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial","SWIFT","Inclusion Criteria:\n\n* planned vaginal delivery\n* singleton vital pregnancy\n* gestational age at delivery \\>= 30+0 weeks\n* maternal weight at admission for delivery \\\u003C100 kg\n\nExclusion Criteria:\n\n* Antithrombotic therapy in pregnancy (therapeutic dosage) until admission for delivery (LMWH, UFH)\n* diagnosis of preeclampsia (ISSHP classification , eclampsia or HELLP syndrome),\n* known history of deep vein thrombosis or pulmonary embolism,\n* known diagnosis of bleeding disorder or thrombophilia,\n* known thrombocytopenia during second half of pregnancy with thrombocytes \\\u003C 100 G\u002FL,\n* known anemia during second half of pregnancy with Hb\\\u003C80 g\u002FL,\n* known sickle cell disease,\n* known malignant tumor(s),\n* participation in another study with investigational drug within the 30 days preceding and during the present study,\n* inability to follow the procedures of the study, e.g. due to language problems,\n* known or suspected non-compliance, drug or alcohol abuse.\n\nExclusion criteria prior randomization\n\n* Maternal fever ≥39.0°C\n* unplanned cesarean delivery is performed,\n* Measured Blood Loss remains \\\u003C 700 mL after administration of 1g tranexamic acid .\n* Postpartum hemorrhage due to occult bleeding (intra-abdominal, retroperitoneal, parametric),","FEMALE","18 Years",{"count":202,"type":203},988,"ESTIMATED","INTERVENTIONAL",[206],"PHASE4","The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH).\n\nSummary of current body of evidence:\n\n* Morbidity and mortality due to PPH is rising.\n* Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials.\n* Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.\n\nTherefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII.\n\nAll participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss \\[MBL\\] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.",[209,210,211,212,213],"Postpartum Hemorrhage","Coagulation Disorder","Coagulation Factor Deficiency","Hemorrhage","Postpartum Complication",[215,216],"Postpartum hemorrhage","coagulation factor XIII","2026-04-21",{"date":219,"type":220},"2026-04-27","ACTUAL",{"date":222,"type":220},"2024-07-09",{"date":224,"type":203},"2028-12-31",{"name":186,"class":6},9]