[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560843":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":37,"locations":26,"responsibleParty":46,"collaborators":48,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":26},{"fullName":5,"class":6},"Unidade Local de Saude do Arco Ribeirinho","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard trauma care","PLACEBO_COMPARATOR","Determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide .",[13],"Drug: Standard trauma care",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard trauma care plus administration of fibrinogen concentrate (FC).","EXPERIMENTAL","The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.",[19],"Drug: Fibrinogen concentrate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fibrinogen concentrate","Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC. The standard of care is determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide. The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.",[15],null,{"type":22,"name":9,"description":24,"armGroupLabels":28,"otherNames":26},[9],[30,33,35],{"name":31,"affiliation":5,"role":32},"Pedro Batarda Sena, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"Francisco Das Neves Coelho, MD",{"name":36,"affiliation":5,"role":32},"Tiago Quaresma, MD",[38,42],{"name":31,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+351964794618","pmcbcs@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Joana Alves Cabrita, MD","+351965139276","joana.alves.cabrita@gmail.com",{"type":47,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[49,52,55,57],{"name":50,"class":51},"Unidade Local de Saúde de São José","INDIV",{"name":53,"class":54},"Unidade Local de Saúde da Arrábida","UNKNOWN",{"name":56,"class":6},"Unidade Local de Saúde Santa Maria",{"name":58,"class":54},"Unidade Local de Saúde Almada-Seixal","100560843","pre-hospital-administration-of-fibrinogen-in-trauma-induced-coagulopathy-100560843",false,"NCT06582420","Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy","Pre-hospital Administration of Fibrinogen Concentrate in Patients With Suspected Trauma-Induced Coagulopathy (PAF-TIC)","PAF-TIC","Inclusion Criteria:\n\n• Adult patients at risk of Trauma Induced Coagulopathy (TIC), with major bleeding or presumed to be bleeding, identified by TIC criteria: mTICCS score \\> 5 or Shock index \\> 0.8.\n\nExclusion Criteria:\n\n* Known adverse reactions to fibrinogen concentrate (FC)\n* Isolated trauma such as traumatic head injury only\n* Need for cardiopulmonary resuscitation (CPR) on the scene or peri-arrest scenarios\n* Deep hypothermia\n* Age below 18 years\n* Pregnancy\n* Prothrombin time ratio superior equal or superior to 1.2 (PTr\\>1.2) at the hospital admission\n* Refusal to participate (if the patients are capable of consenting)","ALL","18 Years",{"count":70,"type":71},52,"ESTIMATED","INTERVENTIONAL",[74],"NA","A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.\n\nThe main endpoints are:\n\n1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and\u002For similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g\u002Fl. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.\n2. Administration feasibility of FC within the prehospital setting.\n\nPatients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.",[77],"Trauma Induced Coagulopathy",[79,80,77,81,82],"Trauma","Coagulopathy","Fibrinogen","Clot","NOT_YET_RECRUITING","2024-09-02",{"date":86,"type":87},"2024-09-19","ACTUAL",{"date":89,"type":71},"2025-01-01",{"date":91,"type":71},"2025-12-31",{"name":5,"class":6}]