Actively Recruiting

Age: 18Years +
All Genders
NCT07043556

Assessment of Artificial Intelligence Algorithms for ROTEM

Led by Ondokuz Mayıs University · Updated on 2025-07-18

144

Participants Needed

2

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Assessment of Artificial Intelligence Algorithms for ROTEM

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Istanbul, Turkey (Türkiye)

Actively Recruiting

2

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Burhan Dost, Assoc. Prof.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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