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NOT YET RECRUITING
NCT07502950

ROTEM Interpretation AI vs Experts

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

View on ClinicalTrials.gov

Summary

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.

Official title: Artificial Intelligence Versus Expert Interpretation of ROTEM: A Prospective Study of Agreement and Clinical Decision-Making

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-09-01

Completion Date

2027-07-01

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

OTHER

Large Language Model (LLM) artificial intelligence assesment

The thromboelastography record will be assessed by LLM based artificial intelligence.