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Assessment of Artificial Intelligence Algorithms for ROTEM

NCT07043556 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-07-18

No results posted yet for this study

Summary

The goal of this observational validation study is to evaluate whether artificial intelligence (AI) models can accurately interpret ROTEM (Rotational Thromboelastometry) data and provide appropriate treatment recommendations in adult patients undergoing elective cardiac or liver transplantation surgery.

The main questions it aims to answer are:

Can AI models (e.g., ChatGPT and Gemini ) accurately determine whether treatment is indicated based on ROTEM parameters? Can AI models correctly identify the type of coagulopathy (e.g., fibrinogen deficiency, platelet dysfunction)? Are the treatment recommendations from AI models concordant with expert clinical consensus? Researchers will compare the decisions made by AI models to a gold standard expert panel to see if AI models can match or approximate expert-level decision-making in interpreting ROTEM outputs.

Participants will:

Undergo elective cardiac or liver transplant surgery. Have standard ROTEM tests performed intraoperatively.

Have their anonymized ROTEM data reviewed independently by:

A panel of 3 clinical experts. AI models (ChatGPT and Gemini) using standardized prompts and ROTEM interpretation guidelines.

Conditions

  • Coagulopathy

Interventions

OTHER

Artificial Intelligence-Based ROTEM Interpretation

A structured artificial intelligence-based evaluation system that analyzes ROTEM (Rotational Thromboelastometry) parameters and provides treatment recommendations. ROTEM case data are converted into standardized clinical scenarios and evaluated by AI models using a predefined template. The AI output is compared to the consensus of expert clinicians regarding the presence and type of coagulopathy and the need for therapeutic intervention (e.g., fibrinogen, protamine, platelets, PCC, plasma). This intervention does not involve any patient-facing activity and is performed on de-identified data only.

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • Burhan Dost, Assoc. Prof. · Ondokuz Mayıs University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-05
Completion
2025-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043556 on ClinicalTrials.gov