[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coagulopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coagulopathy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,76,105,128,152,179,201,232],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100581771","phase-1-a-study-to-learn-about-how-safe-bay-3389934-is-its-suitable-dose-and-how-it-affects-the-participants-with-sepsis-induced-coagulopathy-100581771",false,"NCT06854640","A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy","First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients With Sepsis Induced Coagulopathy","Inclusion Criteria:\n\n* Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.\n* Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.\n* participants with suspected or documented origin of infection.\n* Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000\u002Fmm3 to \\\u003C 150,000\u002Fmm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be \\\u003C 30,000\u002Fmm3.\n* Participants must be receiving treatment in an ICU.\n* Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.\n\nExclusion Criteria:\n\n* Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.\n* Low platelets level or abnormal coagulation status due to any other reason than sepsis.\n* Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists\u002Fwarfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin, metformin\n* Any active malignancy\n* Pregnancy or breastfeeding.\n* Chronic liver disease Child-Pugh Class C.\n* Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery\u002Ftrauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.\n* Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration","ALL","18 Years","80 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Researchers are looking for a better way to treat people who have sepsis induced coagulopathy.\n\nSepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death.\n\nThe main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU).\n\nFor this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as \"adverse events\". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.\n\nParticipants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.\n\nEach participant will be in the study for around 28 days. During the study, the doctors and their study team will:\n\n* Take blood and urine samples,\n* Do physical examinations,\n* Check vital signs such as body temperature, blood pressure and heart rate,\n* Examine heart health using electrocardiogram (ECG)",[27,28],"Sepsis","Coagulopathy",[30,31,32],"DIC","Disseminated intravascular coagulation","Sepsis induced coagulopathy","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2025-03-12",{"date":41,"type":21},"2027-02-15",{"name":43,"class":44},"Bayer","INDUSTRY",20,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100631612","rotem-interpretation-ai-vs-experts-100631612","NCT07502950","ROTEM Interpretation AI vs Experts","Artificial Intelligence Versus Expert Interpretation of ROTEM: A Prospective Study of Agreement and Clinical Decision-Making","ROTEMAI","Inclusion Criteria:\n\nAdult patients (age ≥18 years)\n\n* ROTEM analysis performed using a ROTEM Sigma device as part of routine clinical care\n* Availability of complete ROTEM output (graphical and numerical data)\n* ROTEM measurement obtained in a clinical context where assessment of coagulation status is indicated (e.g., perioperative setting, trauma, or critical illness)\n\nExclusion Criteria:\n\n* ROTEM measurements performed using the HEPTEM channel\n* Incomplete or missing ROTEM data preventing standardized evaluation\n* ROTEM measurements obtained under non-standardized or technically unreliable conditions",{"count":55,"type":21},400,"OBSERVATIONAL","This prospective multicenter observational study aims to evaluate the agreement between artificial intelligence (AI)-based interpretation and expert interpretation of rotational thromboelastometry (ROTEM) findings in clinically relevant settings. ROTEM is widely used to guide hemostatic therapy in perioperative and critically ill patients, but its interpretation is complex and subject to interobserver variability.\n\nThe primary objective is to determine whether AI-based interpretation achieves agreement comparable to variability between expert clinicians. Secondary objectives include comparison of interpretation time, assessment of consistency of AI outputs, and evaluation of potential differences in clinical decision-making.\n\nROTEM datasets will be independently assessed by multiple expert anesthesiologists and by an AI-based model using standardized input. Agreement between methods and variability of interpretation will be analyzed.\n\nThe study aims to determine whether AI-assisted interpretation could serve as a reliable decision-support tool and reduce variability in ROTEM-guided clinical practice.",[28,59,60],"Thromboelastography","Agreement",[62,63,64],"ROTEM","thromboelastography","coagulopathy","NOT_YET_RECRUITING","2026-03-25",{"date":68,"type":37},"2026-03-31",{"date":70,"type":21},"2026-09-01",{"date":72,"type":21},"2027-07-01",{"name":74,"class":75},"Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100473818","phase-3-fibrinogen-early-in-severe-trauma-study-ii-100473818","NCT05449834","Fibrinogen Early In Severe Trauma StudY II","FEISTY II","Inclusion Criteria:\n\n1. Adult affected by trauma (≥18yrs)\n2. Judged to have active haemorrhage by treating clinician\n3. Activation of local MHP and\u002For Transfusion of Emergency Blood Products\n4. FIBTEM A5 ≤ 10mm or TEG FF A5 ≤ 15mm or FibC ≤ 2 g\u002Fl\n\nExclusion Criteria:\n\n1. Injury judged incompatible with survival\n2. Randomisation unable to occur within 6 hours of presentation to hospital\n3. Known pregnancy\n4. Known genetic or drug induced coagulation disorder\n5. Known objection to blood products\n6. Dedicated prior fibrinogen replacement\n7. Participation in a competing study","100 Years",{"count":85,"type":21},900,[87],"PHASE3","Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.\n\nCurrently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.\n\nFibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.\n\nThe timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.\n\nFEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate",[90,91,28],"Trauma","Haemorrhagic Shock",[93,94],"Fibrinogen","Cryoprecipitate","2026-02-03",{"date":97,"type":37},"2026-02-05",{"date":99,"type":37},"2022-11-21",{"date":101,"type":21},"2026-12-01",{"name":103,"class":75},"Australian and New Zealand Intensive Care Research Centre",24,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":17,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":127},"100506473","validation-of-point-of-care-thromboelastography-teg-6s-in-pediatric-patients-100506473","NCT05874843","Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients","Inclusion Criteria:\n\n-Patients less than 18 years of age undergoing elective pediatric surgical care in the operating room at Riley Hospital for Children\n\nExclusion Criteria:\n\n* Known disorder of coagulation pathway(s)\n* Administration of medications that may alter the coagulation cascade\n* Patients in foster care or wards of the court","3 Months",{"count":113,"type":21},125,[115],"NA","The goal of this observational study is to learn about the performance of the TEG6s in normal pediatric patients. The main questions it aims to answer are: What are the normal TEG 6S lab results in normal pediatric patients and how do they compare to existing published reference ranges. Participants and their guardians will be asked to submit a small amount of blood at the beginning of an elective operation for analysis in the TEG 6s machine.",[28],[63],"2025-10-30",{"date":121,"type":37},"2025-10-31",{"date":123,"type":37},"2023-09-11",{"date":101,"type":21},{"name":126,"class":75},"Indiana University",1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":127},"100609401","phase-2-phase-iib-multicenter-randomized-controlled-trial-evaluating-the-efficacy-of-sivelestat-in-patients-with-septic-coagulopathy-100609401","NCT07214103","Phase IIb Multicenter Randomized Controlled Trial Evaluating the Efficacy of Sivelestat in Patients With Septic Coagulopathy","SivelSep","Inclusion Criteria:\n\n* Adults aged 18 to 85 years\n* Patient (male or female) admitted to the ICU with:\n\n  * Septic shock defined by Sepsis-3 criteria: acute, life-threatening organ dysfunction related to a suspected or confirmed infection, requiring vasopressor support to maintain a mean arterial pressure ≥ 65 mmHg and a serum lactate level \\> 2 mmol\u002FL despite adequate fluid resuscitation.\n  * Coagulopathy defined by a SIC score ≥ 4 points.\n* Randomization within 12 hours after the diagnosis of coagulopathy (positive SIC score).\n* Patient affiliated with a national health insurance system.\n* Written informed consent: freely given, dated, and signed.\n\n  * By the patient\n  * Or by a legal representative if the patient is unable to provide consent.\n  * Or through an emergency inclusion procedure if the patient is unable to consent and no family member is available\n\nExclusion Criteria:\n\n* History of hypersensitivity reaction to Sivelestat (the only contraindication for Sivelestat)\n* Patient weight \\> 100 kg\n* Severe chronic liver disease (Child-Pugh C)\n* Contraindication to the use of unfractionated heparin\n* Moribund patient at the time of randomization\n* Limitation of active therapeutic interventions at the time of study inclusion\n* Under legal protection (guardianship, curatorship, or legal safeguard)\n* Pregnancy or breastfeeding\n* Participation in another interventional drug clinical trial","85 Years",{"count":137,"type":21},120,[139],"PHASE2","Sepsis-induced disseminated intravascular coagulation (DIC) is a severe complication occurring in one-third of patients with septic shock, for which no specific treatment currently exists. It results from excessive systemic activation of coagulation and impaired fibrinolysis, leading to the development of disseminated microthromboses. We have recently demonstrated: 1) the contribution of NETs to the hypercoagulability observed in DIC, and 2) the role of neutrophil elastase-bound to NET DNA-in degrading plasminogen, a key factor limiting fibrinolysis and thus preventing the lysis of microthrombi in DIC.\n\nSivelestat is a neutrophil elastase inhibitor used in Japan for the treatment of acute respiratory distress syndrome (ARDS). It has the potential to inhibit: 1) neutrophil activation and the release of inflammatory mediators, and 2) plasminogen degradation, which drives fibrinolytic failure. A recent meta-analysis including 2,050 patients across 15 studies showed that Sivelestat reduced ARDS patient mortality at day 28-30 (RR = 0.81, 95% CI = 0.66-0.98, p = 0.03), decreased mechanical ventilation duration and ICU length of stay, and improved oxygenation.\n\nWe propose to conduct a multicenter, double-blind, placebo-controlled phase IIb trial evaluating the efficacy of Sivelestat in restoring fibrinolysis in patients with septic shock complicated by coagulopathy, defined by a positive SIC score (≥ 4 points).",[142,28],"Septic Shock","2025-10-02",{"date":145,"type":37},"2025-10-09",{"date":147,"type":21},"2026-03-01",{"date":149,"type":21},"2032-12-31",{"name":151,"class":75},"University Hospital, Strasbourg, France",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":160,"sex":16,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":164,"studyType":56,"phases":4,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":127},"100596545","predictive-accuracy-of-plr-and-pnr-in-detecting-etic-100596545","NCT07046858","Predictive Accuracy of PLR and PNR in Detecting ETIC","Predictive Accuracy of Platelet Lymphocyte Ratio & Platelet Neutrophil Ratio in Detecting Early Trauma Induced Coagulopathy","ETIC","Inclusion Criteria:\n\n* All patients with trauma AND\n* Presenting to ED within 6 hours of the event AND\n* The ED Physician sends coagulation profile\n\nExclusion Criteria:\n\n* Treated with intravenous fluids, drugs, whole blood and blood products elsewhere\n* Patients admitted with a non-mechanical mechanism of injury, specifically drowning, hanging,or burns, as these mechanisms may result in a different biologic response than mechanical trauma\n* Patients on known medications affecting coagulation profile or hemogram\n* Patients with known chronic liver disease, chronic renal failure, malignancy, hematological disorders\n* Patients not consenting for the study",true,"12 Years",{"count":163,"type":21},250,"1 Day","Observational study to know what is the predictive accuracy of platelet-neutrophil ratio (PNR) and platelet-lymphocyte ratio (PLR) done in patients presenting to ED( emergency department)within 6 hours of trauma; in detecting early trauma induced coagulopathy during hospital admission",[167,28],"Trauma Injury",[169],"Early trauma induced coagulopathy","2025-06-23",{"date":172,"type":37},"2025-07-02",{"date":174,"type":37},"2023-10-17",{"date":176,"type":21},"2025-11-27",{"name":178,"class":75},"Jubilee Mission Medical College and Research Institute",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":127},"100583575","patient-blood-management-implementation-in-cee-study-100583575","NCT06878105","Patient Blood Management Implementation in CEE Study","Evaluation of Fixed and Personal Assets for Patient Blood Management Implementation in CEE Countries in Practice","CEEPBM","Inclusion Criteria:\n\n* patients above 18 years of age\n* patients undergoing elective medium and high bleeding risk surgical intervention defined as moderate (\\\u003C500 ml) and high (≥ 500 ml)\n* patient consent\n\nExclusion Criteria:\n\n* no patient consent\n* patients under 18 years of age\n* pregnant patients\n* surgery with a low risk of bleeding\n* the patient underwent emergency (non-elective) surgery",{"count":188,"type":21},2000,"The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM training.",[191,28],"Anemia","2025-03-10",{"date":194,"type":37},"2025-03-14",{"date":196,"type":37},"2024-05-27",{"date":198,"type":21},"2025-12-31",{"name":200,"class":75},"Semmelweis University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":127},"100539505","effects-of-bothrops-spp-snake-envenomation-on-willebrand-factor-activity-in-martinique-and-french-guiana-100539505","NCT06304714","Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana","Abnormalities of Plasma Willebrand Factor Activity Induced by Bothrops Snakebites Endemic to Martinique and French Guyana","WBOTHROPS","Inclusion Criteria:\n\n* Men or Women, at least 18 years old\n* Be admitted to the Emergency Department of the Martinique University Hospital or the Cayenne University Hospital\n* Be the victim of a confirmed Bothrops snake bite in Martinique or French Guyana. The formal identification of the snake by the patient or his entourage is imperative.\n* Have a confirmed diagnosis of stage III envenomation (regional oedema of the limb and\u002For moderate general symptoms such as moderate hypotension, malaise, vomiting, abdominal pain, diarrhoea) and stage IV (extensive oedema reaching the trunk and\u002For severe general symptoms such as prolonged hypotension, shock, anaphylactoid reaction, visceral damage)\n* Be able to receive and understand information related to the research\n* Be able to freely give verbal consent to participate in the proposed research\n* Be able to freely give written informed consent to participate in the plasmathèque\n* Be affiliated to the general social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* People who have been treated for snakebite with Bothrops anti-venom Bothrofav® or Antivipmyn-tri®.\n* Known disorders of haemostasis such as haemophilia A (factor VIII deficiency), haemophilia B (factor IX deficiency), vitamin K deficiency, hepato-cellular insufficiency, presence of circulating anticoagulant factors\n* Disseminated intravascular coagulation (DIC)\n* Constitutional and acquired Von Willebrand disease\n* Constitutional and acquired thrombopathies\n* Idiopathic thrombocytopenic purpura\n* Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.",{"count":210,"type":21},30,"In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases \"hemorrhagins\" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.\n\nEnvenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.\n\nThe investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.\n\nThe investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.\n\nThis study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.",[213,214,28,215],"Snake Envenomation","Thrombi","Hemorrhage",[217,218,219,220,221,222],"Snakebite envenomation","French Caribbean (Martinique, French Guiana)","Bothrops species","Von Willebrand Factor","endothelial activity","haemostasis","2024-09-24",{"date":225,"type":37},"2024-09-26",{"date":227,"type":37},"2024-08-02",{"date":229,"type":21},"2025-10-08",{"name":231,"class":75},"University Hospital Center of Martinique",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100561145","frequency-predictors-and-outcome-of-sepsis-induced-coagulopathy-in-critical-care-unit-100561145","NCT06586346","Frequency, Predictors and Outcome of Sepsis Induced Coagulopathy in Critical Care Unit","Inclusion Criteria:\n\n* Patients with 18 years of ago or older who will be admitted to critical care unit with sepsis during period between october 2024 and october 2026.\n\nExclusion Criteria:\n\n* patients under tge age of 18patients with end organ diseases\n* pregnant woman\n* patient with coagulation disorder\n* patient using anticoagulant drugs","75 Years",{"count":240,"type":21},100,"In intensive care units , sepsis remains one of the common causes of mortality and morbidity . The average hospital length of stay for sepsis is twice as long as any other fatal condition . Furthermore, sepsis survivors are at an increased risk of death or a reduced health related quality of life even after discharge from the hospital . Sepsis induces multiple and complex derangements in many systems including the coagulation cascade. The vast majority of septic patients present with hemostatic abnormalities ranging from subclinical coagulopathy to fulminant disseminated intravascular coagulation . During the initial stages of infection coagulation operates as a natural defense mechanism attempting to confine the responsible pathogen and prevent its spread into systematic circulation. However in advanced and severe infections as in sepsis, mass inflammatory cytokine production and release into the circulation lead to significantly deranged hemostatic balance . The coagulation process is activated while anticoagulant mechanisms including fibrinolysis and anticoagulant factors are suppressed. Consequently septic patients are prone to a prothrombotic state through four main mechanisms extrinsic pathway activation, cytokine induced coagulation amplification, anticoagulant pathways suppression, and fibrinolysis impairment .",[28],"2024-09-05",{"date":245,"type":37},"2024-09-19",{"date":247,"type":21},"2024-09-10",{"date":249,"type":21},"2026-08",{"name":251,"class":75},"Assiut University"]