[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581771":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":231,"collaborators":23,"id":233,"slug":234,"hasResults":235,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":23,"eligibilityCriteria":239,"healthyVolunteers":235,"sex":240,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":23,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":55,"whyStopped":23,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 of BAY3389934","EXPERIMENTAL","Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours.",[13],"Drug: BAY3389934",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2 of BAY3389934",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","BAY3389934","Solution for IV infusion",[9,15],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Bayer Clinical Trials Contact","CONTACT","(+)1-888-84 22937","clinical-trials-contact@bayer.com",[31,44,53,63,72,84,94,104,114,123,132,142,154,164,174,183,195,201,211,221],{"facility":32,"status":33,"city":34,"state":23,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":23},"UZ Antwerpen - Intensive Care","NOT_YET_RECRUITING","Edegem","2650","Belgium","BE",{"type":39,"coordinates":40},"Point",[41,42],4.44504,51.15662,{"lat":42,"lon":41},{"facility":45,"status":33,"city":46,"state":23,"zip":47,"country":36,"countryCode":37,"cosmosGeoPoint":48,"geoPoint":52,"contacts":23},"Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care","Liège","4000",{"type":39,"coordinates":49},[50,51],5.56749,50.63373,{"lat":51,"lon":50},{"facility":54,"status":55,"city":56,"state":23,"zip":57,"country":36,"countryCode":37,"cosmosGeoPoint":58,"geoPoint":62,"contacts":23},"Clinique Saint-Pierre d'Ottignies - Intensive Care","RECRUITING","Ottignies-Louvain-la-Neuve","1340",{"type":39,"coordinates":59},[60,61],4.55023,50.66714,{"lat":61,"lon":60},{"facility":64,"status":33,"city":65,"state":23,"zip":66,"country":36,"countryCode":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":23},"Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care","Woluwe-Saint-Lambert","1200",{"type":39,"coordinates":68},[69,70],4.42912,50.84389,{"lat":70,"lon":69},{"facility":73,"status":33,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":23},"CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation","Tours","Centre-Val de Loire","37044","France","FR",{"type":39,"coordinates":80},[81,82],0.70398,47.39484,{"lat":82,"lon":81},{"facility":85,"status":55,"city":86,"state":87,"zip":88,"country":77,"countryCode":78,"cosmosGeoPoint":89,"geoPoint":93,"contacts":23},"Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation","Strasbourg","Grand Est","67091",{"type":39,"coordinates":90},[91,92],7.74553,48.58392,{"lat":92,"lon":91},{"facility":95,"status":55,"city":96,"state":97,"zip":98,"country":77,"countryCode":78,"cosmosGeoPoint":99,"geoPoint":103,"contacts":23},"Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente","Limoges","New Aquitaine","87042",{"type":39,"coordinates":100},[101,102],1.24759,45.83362,{"lat":102,"lon":101},{"facility":105,"status":33,"city":106,"state":107,"zip":108,"country":77,"countryCode":78,"cosmosGeoPoint":109,"geoPoint":113,"contacts":23},"Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare","Angers","Pays de la Loire Region","49100",{"type":39,"coordinates":110},[111,112],-0.55202,47.47156,{"lat":112,"lon":111},{"facility":115,"status":33,"city":116,"state":107,"zip":117,"country":77,"countryCode":78,"cosmosGeoPoint":118,"geoPoint":122,"contacts":23},"Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente","La Roche-sur-Yon","85000",{"type":39,"coordinates":119},[120,121],-1.42757,46.66974,{"lat":121,"lon":120},{"facility":124,"status":33,"city":125,"state":107,"zip":126,"country":77,"countryCode":78,"cosmosGeoPoint":127,"geoPoint":131,"contacts":23},"Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation","Nantes","44000",{"type":39,"coordinates":128},[129,130],-1.55336,47.21725,{"lat":130,"lon":129},{"facility":133,"status":33,"city":134,"state":135,"zip":136,"country":77,"countryCode":78,"cosmosGeoPoint":137,"geoPoint":141,"contacts":23},"Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare","Garches","Île-de-France Region","92380",{"type":39,"coordinates":138},[139,140],2.18232,48.84226,{"lat":140,"lon":139},{"facility":143,"status":33,"city":144,"state":145,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":23},"Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)","München","Bavaria","81377","Germany","DE",{"type":39,"coordinates":150},[151,152],13.46314,48.69668,{"lat":152,"lon":151},{"facility":155,"status":33,"city":156,"state":157,"zip":158,"country":147,"countryCode":148,"cosmosGeoPoint":159,"geoPoint":163,"contacts":23},"Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik","Cologne","North Rhine-Westphalia","51109",{"type":39,"coordinates":160},[161,162],6.95,50.93333,{"lat":162,"lon":161},{"facility":165,"status":55,"city":166,"state":167,"zip":168,"country":147,"countryCode":148,"cosmosGeoPoint":169,"geoPoint":173,"contacts":23},"Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie","Dresden","Saxony","01307",{"type":39,"coordinates":170},[171,172],13.73832,51.05089,{"lat":172,"lon":171},{"facility":175,"status":33,"city":176,"state":167,"zip":177,"country":147,"countryCode":148,"cosmosGeoPoint":178,"geoPoint":182,"contacts":23},"Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin","Leipzig","04103",{"type":39,"coordinates":179},[180,181],12.37129,51.33962,{"lat":181,"lon":180},{"facility":184,"status":33,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":23},"Universitair Medisch Centrum St. Radboud - Intensive Care","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":39,"coordinates":191},[192,193],5.85278,51.8425,{"lat":193,"lon":192},{"facility":196,"status":33,"city":185,"state":186,"zip":197,"country":188,"countryCode":189,"cosmosGeoPoint":198,"geoPoint":200,"contacts":23},"Canisius WIlhelmina Ziekenhuis - Intensive Care","6532 SZ",{"type":39,"coordinates":199},[192,193],{"lat":193,"lon":192},{"facility":202,"status":33,"city":203,"state":204,"zip":205,"country":188,"countryCode":189,"cosmosGeoPoint":206,"geoPoint":210,"contacts":23},"Jeroen Bosch Ziekenhuis - Intensive Care","'s-Hertogenbosch","North Brabant","5223 GZ",{"type":39,"coordinates":207},[208,209],5.30417,51.69917,{"lat":209,"lon":208},{"facility":212,"status":33,"city":213,"state":214,"zip":215,"country":188,"countryCode":189,"cosmosGeoPoint":216,"geoPoint":220,"contacts":23},"Medisch Spectrum Twente - Intensive Care","Enschede","Overijssel","7512 KZ",{"type":39,"coordinates":217},[218,219],6.89583,52.21833,{"lat":219,"lon":218},{"facility":222,"status":33,"city":223,"state":224,"zip":225,"country":188,"countryCode":189,"cosmosGeoPoint":226,"geoPoint":230,"contacts":23},"Erasmus Medisch Centrum - Intensive Care","Rotterdam","South Holland","3015 GD",{"type":39,"coordinates":227},[228,229],4.47917,51.9225,{"lat":229,"lon":228},{"type":232,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":244,"type":245},36,"ESTIMATED","INTERVENTIONAL",[248],"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)",[251,252],"Sepsis","Coagulopathy",[254,255,256],"DIC","Disseminated intravascular coagulation","Sepsis induced coagulopathy","2026-06-22",{"date":259,"type":260},"2026-06-23","ACTUAL",{"date":262,"type":260},"2025-03-12",{"date":264,"type":245},"2027-02-15",{"name":5,"class":6},20]