[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"agreement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:agreement":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100631612","rotem-interpretation-ai-vs-experts-100631612",false,"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","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","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.",[25,26,27],"Coagulopathy","Thromboelastography","Agreement",[29,30,31],"ROTEM","thromboelastography","coagulopathy","NOT_YET_RECRUITING","2026-03-25",{"date":35,"type":36},"2026-03-31","ACTUAL",{"date":38,"type":21},"2026-09-01",{"date":40,"type":21},"2027-07-01",{"name":42,"class":43},"Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.","OTHER"]