[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trauma-induced-coagulopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trauma-induced-coagulopathy":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100600426","point-of-care-fibrinogen-measurement-in-trauma-patients-in-the-emergency-department-100600426",false,"NCT07097337","Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department","POCFIB","Population (base) Adult trauma patients will be identified as follows: (1) by the trauma team leader on admission to the ED or (2) by the research team personnel following a massive transfusion protocol activation. Patients will be assessed for eligibility to enter the trial according to the criteria set out below. If patients are eligible for entry into the study following initial screening, they will be enrolled automatically under deferred consent. Patients will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria detailed below.\n\nInclusion criteria\n\nTo be eligible to participate in this study, a subject must meet the following criteria:\n\n* The participant is judged to be an adult (according to the attending clinician, e.g. 16 years or older) and has sustained traumatic injury\n* The participant is deemed by the attending clinician to have on-going active hemorrhage\n* The major hemorrhage protocol (MTP) is activated or this patient and transfusion is initiated\n\nExclusion criteria\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n* The participant has been transferred from another hospital\n* The trauma team leader deems the injuries incompatible with life","ALL","16 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","Background: Why This Study Matters When someone suffers a severe injury (like from a car crash), they can bleed heavily. One complication doctors often face is something called Trauma-Induced Coagulopathy (TIC). This is a condition where the blood doesn't clot properly, making bleeding worse. The reasons behind TIC are complicated and not fully understood.\n\nOne important substance involved is fibrinogen, a protein that helps blood clot. Low levels of fibrinogen are often the first sign of TIC and tend to be linked with how bad the injury is. Because of this, doctors have been giving trauma patients extra fibrinogen early on, hoping it will help them survive.\n\nHowever, a recent large study (called CRYOSTAT-2) showed that giving high doses of fibrinogen to all trauma patients didn't actually help reduce deaths. This suggests that not everyone needs it-only patients with very low fibrinogen levels (below 1.5 grams per liter) should get it.\n\nThe problem is: it currently takes 30 to 45 minutes to get fibrinogen test results. In emergency situations, that's too slow. So doctors have been guessing who needs it, which might not always be the best approach.\n\nWhat This Study Aims to Do This new study wants to see if a faster, bedside test-called a point-of-care (POC) fibrinogen test-can be used in the Emergency Department (ED) during trauma resuscitations.\n\nMain Goals:\n\nFeasibility: Can the test be done quickly and easily during emergency care?\n\nUsefulness: If the fast test had been available, would doctors have made different decisions-like giving or not giving fibrinogen? And would that have changed outcomes for the patients?\n\nStudy Details Feasibility Study: To see if the test is practical during trauma care.\n\nRetrospective Cohort Study: To look back at patients and see if early test results could have changed decisions or outcomes.\n\nWho's In the Study? Adults over 16 who arrive at the ED with serious trauma and for whom the hospital's Massive Transfusion Protocol was activated (meaning they had major bleeding).\n\nThey must have received at least one unit of blood.\n\nHow the Study Will Work The Test: A small amount of blood (0.15 ml) will be taken from blood that's already being drawn for routine care-so no extra blood draws are needed.\n\nThe POC test (called qLabs Fib) will be done at the same time as standard lab tests.\n\nImportant Note: Doctors won't make decisions based on this fast test for now. It's just being tested for feasibility.\n\nNurses will note how long the test takes and if they had any trouble using it.\n\nLater, researchers will look back at the data to see:\n\n* What the fibrinogen levels were.\n* Whether the fast results could have helped guide better treatment.\n* If outcomes like how much blood was given or survival were affected.\n\nWhy It Matters If the fast test works well, it could lead to\n\n* Faster, more accurate treatment in trauma cases.\n* Less unnecessary use of fibrinogen, saving resources and avoiding possible side effects.\n* Better outcomes for patients by tailoring treatment to their actual needs.",[24,25,26,27,28,29],"Trauma Induced Coagulopathy","Trauma Coagulopathy","Fibrinogen Deficiency","Fibrinogen; Deficiency, Acquired","Massive Transfusion Protocol","Massive Hemorrhage",[31,32,33,34],"point of care fibrinogen","trauma induced coagulopathy","fibrinogen suppletion","fibrinogen","RECRUITING","2026-02-06",{"date":38,"type":39},"2026-02-10","ACTUAL",{"date":41,"type":39},"2025-11-01",{"date":43,"type":20},"2027-03-01",{"name":45,"class":46},"Erasmus Medical Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100560843","pre-hospital-administration-of-fibrinogen-in-trauma-induced-coagulopathy-100560843","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)","18 Years",{"count":58,"type":20},52,"INTERVENTIONAL",[61],"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.",[24],[65,66,24,67,68],"Trauma","Coagulopathy","Fibrinogen","Clot","NOT_YET_RECRUITING","2024-09-02",{"date":72,"type":39},"2024-09-19",{"date":74,"type":20},"2025-01-01",{"date":76,"type":20},"2025-12-31",{"name":78,"class":79},"Unidade Local de Saude do Arco Ribeirinho","OTHER_GOV","Trauma-induced Coagulopathy"]