[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615286":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":79,"collaborators":10,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":10,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":10,"enrollmentInfo":92,"targetDuration":10,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Umraniye Education and Research Hospital","OTHER_GOV",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"PCC group",null,"patients receiving PCC during resuscitation",[13],"Procedure: Number of Participants with massive blood transfusion",{"label":15,"type":10,"description":16,"interventionNames":17},"rFVIIa group","patients receiving rFVIIa",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Combination group","patients receiving both PCC and rFVIIa",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Control group","patients who received standard resuscitation without PCC or rFVIIa",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"PROCEDURE","Number of Participants with massive blood transfusion","evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.",[19,23,9,15],[33],{"name":34,"affiliation":35,"role":36},"AYTEN SARAÇOĞLU, Prof,MD","Florida University Jacksonville","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Ayten SARAÇOĞLU, Prof,MD","CONTACT","+1 (904) 524-4331","anesthesiayten@gmail.com",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":46},"Tolga SARAÇOĞLU, Prof,MD","+1 (904) 524-5932","kemaltolgasaracoglu@gmail.com",[48,68],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"UF Health Jacksonville (Shands Hospital)","RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-81.65565,30.33218,{"lat":60,"lon":59},[63,66],{"name":64,"role":40,"phone":65,"phoneExt":10,"email":46},"TOLGA Saraçoğlu, prof,md","904-524-5932",{"name":67,"role":40,"phone":41,"phoneExt":10,"email":42},"AYTEN Saraçoğlu, PROF,MD",{"facility":49,"status":50,"city":51,"state":52,"zip":69,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"32218",{"type":57,"coordinates":71},[59,60],{"lat":60,"lon":59},[74,77],{"name":75,"role":40,"phone":76,"phoneExt":10,"email":42},"AYTEN SARAÇOĞLU, PROF,MD","904-524-4331",{"name":78,"role":40,"phone":45,"phoneExt":10,"email":46},"TOLGA SARAÇOĞLU, PROF,MD",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Zeliha Alicikus","Head of Anesthesiology and Reanimation department,Assoc Prof","100615286","comparative-outcomes-of-pcc-and-recombinant-activated-factor-viia-in-trauma-associated-massive-transfusion-100615286",false,"NCT07290634","Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion","Comparative Outcomes of Prothrombin Complex Concentrate and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion: A Retrospective Cohort Study","Inclusion Criteria:\n\n* Adults ≥18 years\n* Trauma patients directly admitted from the scene with highest-level trauma activation: Injury -Severity Score (ISS) \\>15.\n* Requirement for massive transfusion, defined as ≥3 units packed red blood cells (PRBC) within the first hour or ≥10 PRBC within the first 24 hours\n\nExclusion Criteria:\n\n* Traumatic cardiac injury\n* Death anticipated within the first hour of admission: ISS score \\>49\n* Pre-injury anticoagulant therapy\n* Known pregnancy\n* Pre-injury terminal illness","ALL","18 Years",{"count":93,"type":94},4,"ESTIMATED","OBSERVATIONAL","This study aims to compare the incidence of thromboembolic complications among trauma patients receiving PCC, rFVIIa, both agents, or neither during massive transfusion. Secondary objectives include comparing mortality, transfusion requirements, intensive care unit (ICU) and hospital length of stay, ventilator-free days, and the incidence of transfusion-associated adverse events such as transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO). Subgroup analyses will evaluate outcomes in patients with and without laboratory-confirmed TIC (INR \\>1.2).",[98,99,100],"Thromboembolus","Massive Blood Transfusion; Thrombocytopenia","Trauma","2026-04-11",{"date":103,"type":104},"2026-04-14","ACTUAL",{"date":106,"type":94},"2026-04-30",{"date":108,"type":94},"2026-06-30",{"name":81,"class":6},2]