[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trauma-coagulopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trauma-coagulopathy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,78,105,135,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100641590","stability-of-blood-clotting-products-stored-in-emergency-ambulances-under-real-world-conditions-100641590",false,"NCT07646964","Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions","Stability of Human Fibrinogen (Fibryga) and Lyophilized Human Plasma (Octaplas LG AB) Under Real-World Prehospital Emergency Medical Service Storage Conditions: A Prospective Observational Study","STABLE-EMS","Inclusion Criteria:\n\n* Fibryga samples stored in the participating ground-based EMS ambulance.\n* Octaplas LG AB samples stored in the participating ground-based EMS ambulance.\n* Samples available for laboratory analysis at the predefined study time points.\n* Samples exposed to routine operational storage conditions during the study period.\n\nExclusion Criteria:\n\n* Samples with damaged packaging.\n* Samples with incomplete storage documentation.\n* Samples accidentally removed from the designated storage system during the observation period.\n* Samples unavailable for laboratory analysis.\n* Samples exposed to conditions not representative of routine EMS operation.","ALL",{"count":19,"type":20},2,"ESTIMATED","OBSERVATIONAL","Emergency medical service (EMS) vehicles are exposed to a wide range of environmental conditions, including high temperatures during summer months. These conditions may affect the stability and quality of medications and blood products carried for emergency treatment.\n\nThis observational study aims to evaluate the stability of human fibrinogen concentrates and human plasma proteins (Octaplas) when stored under routine operating conditions in a ground-based EMS ambulance in Graz, Austria. Drug samples will be analyzed monthly over a four-month period and compared with reference samples stored under recommended conditions. In addition, temperature inside the storage containers and the vehicle will be continuously monitored.\n\nThe study will assess whether prolonged exposure to real-world prehospital storage conditions affects product stability and whether any changes are associated with environmental factors. The findings may help determine whether current storage practices in EMS vehicles are adequate for maintaining the quality of these blood coagulation products.",[24,25],"Exanguination","Trauma Coagulopathy",[27,28,29,30,31,32],"Prehospital Care","Drug Storage","Temperature Monitoring","Fibrinogen Concentrate","Lyophilized Plasma","Coagulation Products","NOT_YET_RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":20},"2026-07-01",{"date":41,"type":20},"2026-11-30",{"name":43,"class":44},"Medical University of Graz","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100600426","point-of-care-fibrinogen-measurement-in-trauma-patients-in-the-emergency-department-100600426","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","16 Years",{"count":54,"type":20},150,"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.",[57,25,58,59,60,61],"Trauma Induced Coagulopathy","Fibrinogen Deficiency","Fibrinogen; Deficiency, Acquired","Massive Transfusion Protocol","Massive Hemorrhage",[63,64,65,66],"point of care fibrinogen","trauma induced coagulopathy","fibrinogen suppletion","fibrinogen","RECRUITING","2026-02-06",{"date":70,"type":37},"2026-02-10",{"date":72,"type":37},"2025-11-01",{"date":74,"type":20},"2027-03-01",{"name":76,"class":44},"Erasmus Medical Center",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":77},"100584575","implementation-of-an-empiric-transfusion-bundle-for-out-of-hospital-patients-with-haemorrhagic-shock-100584575","NCT06891131","Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock","Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock: a Prospective Observational Study C-TOP - Coagulation Therapy for Out-of-Hospital Patients","C-TOP","Inclusion Criteria:\n\n* aged, or believed to be aged\n* 18 years or above\n* confirmed or suspected life-threatening bleeding from trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)\n* need for volume replacement therapy.\n\nExclusion Criteria:\n\n* patient with known recent history of thromboembolic events within the last 6 months\n* known or suspected pregnancy at presentation\n* patient with known refusal of a participation in this clinical trial.","18 Years",{"count":88,"type":20},10,"The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid)",[91,25],"Haemorrhagic Shock",[93,94,95,96],"Trauma","coagulopathy","haemmorhage","transfusion","2025-12-09",{"date":99,"type":37},"2025-12-17",{"date":101,"type":37},"2025-06-01",{"date":103,"type":20},"2027-06-01",{"name":43,"class":44},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":132,"locationsCount":134},"100579175","viscoelastic-tests-vet-versus-conventional-coagulation-tests-cct-for-management-of-trauma-induced-coagulopathy-100579175","NCT06820879","Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy","Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy: Opened, Randomized, Two-Parallel, Controlled Trial.VISCOTAC","VISCOTAC","Inclusion Criteria:\n\n* Age 18 years or older\n* Blunt or penetrating injury\n* Less than 3 hours after a trauma AND less than 1 hour after trauma room admission\n* One of the following criteria:\n\n  * Severe trauma in shock (shock index \\> 0.9 or SBP \\\u003C 90 mmHg) or with anemia (hemoglobin \\\u003C 11 g.dL-1) and at least 1 of the following criteria:\n\n    * Positive extended-FAST (Focused Assessment with Sonography for Trauma, ultrasound) finding liquid\n    * Severe bone injury :\n\n      * Fracture of at least two long bones\n      * Amputation above the knee or elbow\n    * Open fracture of the pelvis and\u002For mechanically unstable pelvis\n  * Severe trauma with a high probability of having a TIC (PTratio \\> 1.20) according to the TIC score (score value ≥ 6 - cf. appendix 2)\n* Emergency procedure with secondary informed consent signed by the patient\n\nExclusion Criteria:\n\n* Known pregnancy at admission\n* Transfer from another hospital\n* Cardiac arrest before randomization\n* Patient with devastating injuries expected to die within the first hour post-admission\n* Massive head injury with GCS 3 and bilateral mydriasis\n* Pre-hospital transfusion of RBCs unit or coagulation factors concentrates\n* No tranexamic acid before hospital admission\n* Patient with uncontrolled major bleeding on arrival with direct admission to the operating room for rescue surgery\n* Conventional or viscoelastic assay before inclusion\u002Frandomization\n* Hypothermia \\\u003C 33°C\n* Known use of oral anticoagulants (VKA or DOACs)\n* Known congenital hemostasis abnormality\n* Predictable transfer to another hospital \\\u003C12 hours after admission\n* Patients protected by articles L1121-6 and L1121-7 of the Public Health Code, adults subject to legal protection measures\n* Patient not affiliated to a social security scheme\n* Patient included in other interventional study on coagulopathy.",{"count":114,"type":20},316,"INTERVENTIONAL",[117],"NA","Traumatic coagulopathy is a complex, multifactorial event that occurs in 20-30% of patients on admission. It increases mortality, and its treatment is one of the main priorities in the early management of severely injured patients. Diagnosis of coagulopathy has traditionally been based on conventional coagulation tests (CCTs), which provide an assessment of patients' coagulation in over 60 minutes. Over the past fifteen years, viscoelastic tests (VETs) have been proposed, providing a more rapid result (≤ 10 min) and can guide the administration of labile blood products (LBP). Various studies, mainly retrospective, have shown that the use of VETs is associated with a significant reduction in the use of LBP and the incidence of massive transfusions (MT).\n\nFor example, it has been showed that the use of VETs was accompanied by a reduction in the administration of LBP and more particularly of RBC (Red blood cell concentrate) (4.8 units vs. 1.9 units). The investigators obtained the same result on a larger number of patients, with a further reduction in the administration of other LBP and in the incidence of MT (33% vs. 8%, p\\\u003C0.01).\n\nHowever, the main limitation of these 2 studies is that the results may not have been due solely to the use of ROTEM, but rather to a care package combining the use of ROTEM with the administration of tranexamic acid and the implementation of Damage Control Surgery techniques.\n\nTo avoid this methodological criticism, we recently compared 2 contemporary French cohorts (2012-2019), in which patients had similar management of traumatic injuries, with the exception of the type of coagulation tests: CCT vs. VET. The use of VET s was associated with an increase in the number of patients alive at 24h without MT (76% vs. 55%, p\\\u003C0.001), but also with a sharp reduction in the administration of all LBPs.\n\nThis composite criterion associating the occurrence of a MT with survival at 24 hours after hospital admission was the primary endpoint of the randomized iTACTIC study. iTACTICS was published in 2021, and aimed to compare in severely injured patients 2 strategies for the diagnosis and treatment of coagulopathies, based on CCT in one arm and VET in the other. In this work, the use of VET was not associated with an improvement in the proportion of patients alive at 24 hours without MT (64% vs. 67%, OR 1.15, CI95%: 0.8-1.7), nor with any of the other criteria studied. The main limitation of this study is that less than a third of the patients included had a coagulopathy on admission. The probability of receiving LBP was therefore low. In the subgroup of the most severe patients, an improvement in the primary endpoint was observed for patients randomized to the VET group. The small sample size and subgroup analysis, however, limited the significance of this result.\n\nAll these elements suggest that it is necessary :\n\n* to use a composite endpoint rather than a single endpoint (mortality) for the evaluation of VET-based strategies, combining early mortality with the occurrence of a transfusion event.\n* conduct a randomized trial comparing the use of VETs with that of CCTs in trauma patients with a high probability of coagulopathy on admission to hospital.",[25],[121,122,123,124,125],"Coagulopathy","coagulation tests","viscoelastic tests","massives transfusions","labile blood products","2025-07-10",{"date":128,"type":37},"2025-07-11",{"date":130,"type":20},"2025-10-01",{"date":103,"type":20},{"name":133,"class":44},"Hospices Civils de Lyon",7,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":77},"100584611","rotem-in-sepsis-trauma-outcome-in-intensive-care-100584611","NCT06891599","ROTEM in Sepsis Trauma Outcome in Intensive Care","Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)","ROSTIC","Inclusion Criteria:\n\nTrauma patients:\n\nTrauma alarm activated at hospital admission New Injury Severity Score (NISS) \\> 15 Transfer to hospital within 7 days of trauma with NISS \\> 15\n\nSepsis patients:\n\nMeeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission\n\nControl group:\n\nPatients undergoing elective surgery without expected coagulopathy\n\nExclusion Criteria:\n\nTrauma patients:\n\nIsolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age \\\u003C18 years\n\nSepsis patients:\n\nAge \\\u003C18 years\n\nControl patients:\n\nOngoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age \\\u003C18 years",{"count":144,"type":20},600,"This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.",[147,25],"Sepsis - to Reduce Mortality in the Intensive Care Unit",[149,150,93,121],"Sepsis","ROTEM","2025-03-20",{"date":153,"type":37},"2025-03-24",{"date":155,"type":37},"2024-11-01",{"date":157,"type":20},"2026-12-31",{"name":159,"class":160},"Region Stockholm","OTHER_GOV",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":115,"phases":171,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":77},"100572714","phase-4-tranexamic-acid-in-patients-with-traumatic-bleeding-based-on-dynamic-monitoring-of-thromboelastography-100572714","NCT06736860","Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography","Early and Precise Application and Evaluation of Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography","Inclusion Criteria:\n\n1. . trauma patients 18 -80 years of age (50 points \\> trauma ISS score \\> 16);\n2. . hypotension (systolic blood pressure ≤ 90 mm Hg) and\u002For tachycardia (heart rate ≥ 110 beats\u002Fmin);\n3. . receiving a 1 g TXA push within 3 h of the injury, with the push completed within 10 min of arrival at the hospital.\n4. . signing the informed consent form.\n\nExclusion Criteria:\n\n1. .Coagulation abnormalities due to co-morbid hematologic or autoimmune diseases\n2. Inability to establish venous or intraosseous access\n3. Pregnant women\n4. Traumatic cardiac arrest for more than 5 minutes\n5. Failure of cardiopulmonary resuscitation\n6. Penetrating brain injury\n7. Drowning or hanging -","80 Years",{"count":170,"type":20},580,[172],"PHASE4","Trauma is an important global public health problem and is the leading cause of death in people under 40 years old. Studies have shown that early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours ( 1+1 regimen) is effective in reducing mortality in trauma patients, but there is a residual risk of death. This clinical study utilized real-time dynamic monitoring of coagulation fibrinolytic status in trauma patients using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA (1+X regimen) in addition to the administration of 1 g of TXA intravenously and to compare the two mortality rates, thus guiding the early and precise use of TXA in trauma patients to potentially reduce mortality in trauma patients while decreasing thromboembolic risk. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, no relevant studies have been reported. This study has important clinical significance for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.",[25],[25,176,177],"tranexamic acid","Thromboelastography","2024-12-15",{"date":180,"type":37},"2024-12-17",{"date":182,"type":37},"2024-08-01",{"date":184,"type":20},"2028-12-31",{"name":186,"class":44},"Nanfang Hospital, Southern Medical University"]