RecruitingNCT07043556

Assessment of Artificial Intelligence Algorithms for ROTEM

Assessment of Artificial Intelligence Algorithms for ROTEM Analysis in Coagulation Management


Sponsor

Ondokuz Mayıs University

Enrollment

144 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Adult patients undergoing elective cardiac surgery (CABG, valve surgery, aortic procedures)
  • Adult patients undergoing liver transplantation
  • Availability of complete ROTEM results (EXTEM, INTEM, FIBTEM, +/- HEPTEM, APTEM)
  • Informed written consent obtained

Exclusion Criteria4

  • Incomplete or technically invalid ROTEM data
  • Pediatric patients (<18 years)
  • Refusal to participate or lack of informed consent
  • Emergency and redo surgeries

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Interventions

OTHERArtificial 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.


Locations(2)

İstanbul Aydın Üniversitesi Sağlık Uygulama ve Araştırma Merkezi Medical Park Florya Hastanesi

Istanbul, Turkey (Türkiye)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

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NCT07043556


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