Not Yet RecruitingNot Applicable

ROTEM Interpretation AI vs Experts

400 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Agreement between AI-based and expert interpretation of ROTEM findings

Timeframe: Up to 24 hours after ROTEM measurement (time required for interpretation and data recording).

Trial details

NCT IDNCT07502950

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-01

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