UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042452 |
|---|---|
| Receipt number | 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 12:00:22 |
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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
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
hayasakatatsuya1101@gmail.com
Sponsor or person
Institute
Yamagata University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048461
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
