Assessment of Artificial Intelligence Algorithms for ROTEM

NCT07043556 | Recruiting

• 1 other identifier: ROTEM-AI
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• treatment

  Agreement (yes/no) between AI model and expert panel on whether treatment is indicated.

  1 hour

Secondary Outcomes (2)

• Agreement on Type of Coagulopathy as Determined by ROTEM Analysis Between AI Model and Expert Panel

  1 Hour

• Concordance of ROTEM-Based Treatment Recommendations Between AI and Expert Panel

  1 Hour

Interventions

Artificial Intelligence-Based ROTEM Interpretation OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients (aged 18 years and older) undergoing elective cardiac surgeries-including coronary artery bypass grafting (CABG), valve surgery, and aortic procedures-and elective liver transplantation procedures. All participants will have complete and analyzable intraoperative ROTEM (Rotational Thromboelastometry) data available. Only patients who are able to provide written informed consent will be enrolled. Emergency cases, pediatric patients, and those with technically invalid ROTEM results will be excluded.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (2)

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

Istanbul, Turkey (Türkiye)

RECRUITING

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Burhan Dost, Assoc. Prof.

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burhan Dost, Assoc. Prof.

CONTACT

+90 532 704 24 93; burhandost@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffessor

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion: December 5, 2025
• Study Completion: December 15, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years

Locations

TU (2)