Actively Recruiting
Assessment of Artificial Intelligence Algorithms for ROTEM Analysis in Coagulation Management
Led by Ondokuz Mayıs University · Updated on 2025-07-18
144
Participants Needed
2
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether artificial intelligence (AI) models can accurately interpret ROTEM (Rotational Thromboelastometry) data and make treatment recommendations for adult patients undergoing elective cardiac or liver transplant surgery. This observational validation study aims to compare AI models' decisions to those of expert clinicians to see if AI can match expert-level interpretation in detecting coagulopathy types and suggesting treatments. The study uses de-identified ROTEM data collected during surgery, which is converted into clinical vignettes for review. AI models such as ChatGPT and Gemini analyze these standardized ROTEM parameters and recommend treatments following established ROTEM-guided transfusion protocols. Their outputs are compared to a panel of three clinical experts, forming the gold standard for diagnosis and treatment decisions. Participants will undergo standard ROTEM testing during their elective surgery. Researchers will evaluate agreement between AI and expert panels on whether treatment is needed and on the type of coagulopathy present. The study involves answering 14 structured clinical questions for each case, with results measured by accuracy and concordance metrics. No patient treatment is changed based on AI results, and all data is anonymized with informed consent obtained. The study timeline extends through December 2025.
CONDITIONS
Brief Title
Assessment of Artificial Intelligence Algorithms for ROTEM
Who Can Participate
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants' ROTEM (Rotational Thromboelastometry) results are collected and converted into structured clinical scenarios for assessment of coagulation status.
1 visit (in-person) during elective surgery
Duration - Analysis completed within 1 hour post-surgery
The collected ROTEM data is analyzed by artificial intelligence models and expert clinicians to evaluate diagnostic accuracy and treatment recommendations without affecting patient care.
No additional visits required; analysis performed on de-identified data
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
Research Team
B
Burhan Dost, Assoc. Prof.
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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