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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042452
Receipt No. R000048461
Scientific Title Evaluation of postoperative hemorrhage in cardiac surgery using image analysis system and Machine learning
Date of disclosure of the study information 2020/12/01
Last modified on 2021/05/05

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Basic information
Public title Evaluation of postoperative hemorrhage in cardiac surgery using image analysis system and Machine learning
Acronym Evaluation of postoperative hemorrhage in cardiac surgery using image analysis system and Machine learning
Scientific Title Evaluation of postoperative hemorrhage in cardiac surgery using image analysis system and Machine learning
Scientific Title:Acronym Evaluation of postoperative hemorrhage in cardiac surgery using image analysis system and Machine learning
Region
Japan

Condition
Condition Patients who have undergone open heart surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this project is to create a classifier (system) that can discriminate post-operative blood loss and cases requiring reopening of the chest in open heart surgery from surgical images using an image analysis system and machine learning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To create a classifier (system) that can identify cases that require reopening of the heart in open heart surgery. Then, create a receiver operating characteristic curve for the classifier and determine the area under the curve, sensitivity and specificity.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent open heart surgery at Yamagata University Hospital between January 2010 and December 2020 will be included
Key exclusion criteria Cases with missing image data
Cases with missing blood loss data
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Hayasaka
Organization Yamagata University Faculty of Medicine
Division name Department of Anesthesia
Zip code 9909585
Address 2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL 023-628-5400
Email hayasakatatsuya1101@gmail.com

Public contact
Name of contact person
1st name tatsuya
Middle name
Last name hayasaka
Organization Yamagata University Faculty of Medicine
Division name Department of Anesthesia
Zip code 9909585
Address 2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL 023-628-5400
Homepage URL
Email hayasakatatsuya1101@gmail.com

Sponsor
Institute Yamagata University Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethical Review Committee of Yamagata University Faculty of Medicine
Address 2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
Tel 0236285015
Email ikekenkyu@jm.kj.yamagata-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 11 Month 01 Day
Date of IRB
2020 Year 10 Month 31 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients who had open heart surgery performed at Yamagata University Hospital between January 2010 and December 2020 will be included in the study. Videos of open heart surgery performed during the above period are reviewed, and the images just before chest closure are extracted. The images are subjected to machine learning using Scikit-Learn to create a system for supervised learning that predicts the blood loss in the 12 hours after the surgery from the images immediately before chest closure. We use images as input and bleeding volume as output, with 80% of the data as train data and 20% as test data.

As a secondary evaluation, we will create a system for predicting postoperative blood loss using preoperative patient data (age, sex, height, weight, temperature, heart rate, blood pressure, oxygenation capacity, electrolytes, renal function, liver function, white blood cell count, red blood cell count, platelet count, fibrinogen concentration, cardiac function, etc.).

Management information
Registered date
2020 Year 11 Month 13 Day
Last modified on
2021 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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