ROTEM Interpretation AI vs Experts

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Conditions studied: Coagulopathy, Thromboelastography, Agreement

In brief

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.

Key facts

Study ID

NCT07502950

Run by

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

People needed

400

Starts

2026-09-01

Expected to finish

2027-07-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (age ≥18 years)
• 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)

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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