ROTEM Interpretation AI vs Experts
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMasarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
About this trial
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.
The 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.
ROTEM 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.
The study aims to determine whether AI-assisted interpretation could serve as a reliable decision-support tool and reduce variability in ROTEM-guided clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ROTEM analysis performed using a ROTEM Sigma device as part of routine clinical care
Availability of complete ROTEM output (graphical and numerical data)
ROTEM measurement obtained in a clinical context where assessment of coagulation status is indicated (e.g., perioperative setting, trauma, or critical illness)
Disqualifiers
ROTEM measurements performed using the HEPTEM channel
Incomplete or missing ROTEM data preventing standardized evaluation
ROTEM measurements obtained under non-standardized or technically unreliable conditions
Trial population
The study population will consist of adult patients undergoing rotational thromboelastometry (ROTEM) as part of routine clinical care in participating centers. Patients will be recruited from perioperative and intensive care settings, including major surgery, trauma, and critical illness, where assessment of coagulation status is clinically indicated. This study reflects real-world practice, with no modification of standard care. The unit of analysis will be individual ROTEM measurements rather than individual patients, as repeated measurements may occur during clinical management. Only ROTEM datasets with complete graphical and numerical outputs and meeting predefined quality criteria will be included.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Large Language Model (LLM) artificial intelligence assesment
Other interventionThe thromboelastography record will be assessed by LLM based artificial intelligence.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Patients indicated for thromboelastography.1 intervention
Trial outcomes
Primary outcomes
1
Agreement between AI-based and expert interpretation of ROTEM findings
Agreement between artificial intelligence (AI)-based interpretation and expert interpretation of ROTEM findings will be assessed and compared to inter-expert agreement. Agreement will be evaluated for predefined clinical decision outputs, including: * presence of coagulation disorder (yes/no), * identification of dominant coagulation abnormality (categorical), * selection of therapeutic intervention (categorical), * and recommended treatment dose (continuous). Agreement will be quantified using appropriate statistical methods for categorical and continuous data (e.g., Cohen's/Fleiss' kappa and intraclass correlation coefficients).
Time frame
Up to 24 hours after ROTEM measurement (time required for interpretation and data recording).Secondary outcomes
1
Interpretation time
Time required for interpretation of ROTEM findings by expert clinicians compared to AI-based interpretation. For experts, time will be measured from presentation of the ROTEM result to completion of responses. For AI, time will be measured from submission of the standardized query to completion of output generation.
Time frame
Up to 24 hours after ROTEM measurement.2
Consistency of interpretation (intra-method variability)
Variability of AI-based interpretation across repeated independent runs will be assessed and compared with inter-expert variability. Consistency will be evaluated for all predefined outputs (diagnosis, treatment, dosing).
Time frame
Up to 24 hours after ROTEM measurement3
Proportion of clinically discordant decisions
Proportion of cases in which AI-based interpretation differs from expert interpretation in clinically relevant outputs, including: * disagreement in diagnosis of coagulation disorder, * disagreement in selected treatment strategy, * or clinically relevant difference in recommended dose.
Time frame
Up to 24 hours after ROTEM measurement4
Inter-expert agreement
Agreement between individual expert clinicians in interpretation of ROTEM findings will be evaluated to define baseline interobserver variability and provide a reference for comparison with AI-based interpretation.
Time frame
Up to 24 hours after ROTEM measurementOther outcomes
1
Potential treatment change
Proportion of disagreement between expert panel and LLM based AI that would lead to treatment change.
Time frame
Up to 24 hours after ROTEM measurementLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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