NCT06594484

Brief Summary

In this study, we compared perioperative bleeding prediction scores with our machine learning-based prediction system in predicting the need for erythrocyte suspension during cardiovascular surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 6, 2024

Last Update Submit

September 10, 2024

Conditions

Keywords

Machine LearningCardiovascular SurgeryPerioperative BleedingErythrocyte TransfusionPredictive Modeling

Outcome Measures

Primary Outcomes (1)

  • ML algorithm versus traditional scoring in predicting ES needs

    The success of the ML-based algorithm in correctly predicting the ES need will be calculated.

    During the intraoperative period Cardiac Surgery

Secondary Outcomes (1)

  • Deterdetermining the most effective method for predicting ES needs using traditional scores

    During the intraoperative period Cardiac Surgery

Other Outcomes (1)

  • ML algorithm of combination of scores

    During the intraoperative period Cardiac Surgery

Study Arms (1)

General Anesthesia Group

The need for ES was recorded in patients undergoing cardiovascular surgery.

Other: Ml Based Algorithm 1Other: Ml Based Algroithm 2Other: Bleeding Scores

Interventions

The values in the ML algorithm were selected according to logistic regression analysis and the values used in the other six scores tested. The success rate of the constructed networks correct predictions was considered as the success rate of the algorithm. The usefulness of the test was determined through AUROC analysis. Two algorithms were tested in our study. In the first algorithm (ML1), the dependent variable was erythrocyte suspension (ES) consumption, and the independent variables included patients; demographic data, laboratory data, and operational data

General Anesthesia Group

is an Ml algorithm created by combining commonly used bleeding scores

General Anesthesia Group

ACTION CRUSCADE TRACK WILL-BLEED PAPWORTH TRUST ACTAPORT skores used to predict ES need

General Anesthesia Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Complete files from the data of patients undergoing elective cardiac surgery in Kocaeli City Hospital operating rooms will constitute the study data.

You may qualify if:

  • Data from patients who underwent isolated CABG surgeries in the cardiac and vascular surgery operating rooms between 01.01.2023 and 01.01.2024 were evaluated.

You may not qualify if:

  • Missing Data
  • Emergency surgery
  • İntraoperative mortality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41100, Turkey (Türkiye)

Location

Related Publications (5)

  • Park J, Bonde PN. Machine Learning in Cardiac Surgery: Predicting Mortality and Readmission. ASAIO J. 2022 Dec 1;68(12):1490-1500. doi: 10.1097/MAT.0000000000001696. Epub 2022 May 9.

    PMID: 35544455BACKGROUND
  • El-Sherbini AH, Shah A, Cheng R, Elsebaie A, Harby AA, Redfearn D, El-Diasty M. Machine Learning for Predicting Postoperative Atrial Fibrillation After Cardiac Surgery: A Scoping Review of Current Literature. Am J Cardiol. 2023 Dec 15;209:66-75. doi: 10.1016/j.amjcard.2023.09.079. Epub 2023 Oct 21.

    PMID: 37871512BACKGROUND
  • Shahian DM, Lippmann RP. Commentary: Machine learning and cardiac surgery risk prediction. J Thorac Cardiovasc Surg. 2022 Jun;163(6):2090-2092. doi: 10.1016/j.jtcvs.2020.08.058. Epub 2020 Aug 24. No abstract available.

    PMID: 32951875BACKGROUND
  • Miles TJ, Ghanta RK. Machine learning in cardiac surgery: a narrative review. J Thorac Dis. 2024 Apr 30;16(4):2644-2653. doi: 10.21037/jtd-23-1659. Epub 2024 Apr 24.

    PMID: 38738250BACKGROUND
  • Tseng PY, Chen YT, Wang CH, Chiu KM, Peng YS, Hsu SP, Chen KL, Yang CY, Lee OK. Prediction of the development of acute kidney injury following cardiac surgery by machine learning. Crit Care. 2020 Jul 31;24(1):478. doi: 10.1186/s13054-020-03179-9.

    PMID: 32736589BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

February 22, 2024

Primary Completion

May 22, 2024

Study Completion

May 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations