UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062176 |
|---|---|
| Receipt number | R000071151 |
| Scientific Title | Retrospective Study on Predicting Intraoperative Blood Transfusion Requirements in Cardiac Surgery Using Lumbar Vertebral CT Values Exploration of a Novel Predictive Indicator Through a Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/08 18:31:35 |
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Basic information
Public title
Retrospective Study on Predicting Intraoperative Blood Transfusion Requirements in Cardiac Surgery Using Lumbar Vertebral CT Values
Exploration of a Novel Predictive Indicator Through a Retrospective Cohort Study
Acronym
Retrospective Study on Predicting Intraoperative Blood Transfusion Requirements in Cardiac Surgery Using Lumbar Vertebral CT Values
Exploration of a Novel Predictive Indicator Through a Retrospective Cohort Study
Scientific Title
Retrospective Study on Predicting Intraoperative Blood Transfusion Requirements in Cardiac Surgery Using Lumbar Vertebral CT Values
Exploration of a Novel Predictive Indicator Through a Retrospective Cohort Study
Scientific Title:Acronym
Retrospective Study on Predicting Intraoperative Blood Transfusion Requirements in Cardiac Surgery Using Lumbar Vertebral CT Values
Exploration of a Novel Predictive Indicator Through a Retrospective Cohort Study
Region
| Japan |
Condition
Condition
cardiothoracic surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
| Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to retrospectively evaluate whether lumbar vertebral CT values can serve as a predictive factor for intraoperative transfusion requirements in cardiac surgery, and to construct a more accurate prediction model
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1Association between lumbar CT values and total intraoperative transfusion volume (mL, units)
2Association between lumbar CT values and postoperative daily bleeding volume and transfusion volume during drain placement
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients (over18 years) who underwent cardiac surgery (coronary artery bypass grafting, valve replacement/repair) at our institution between October 1, 2023, and October 30, 2025. Aortic surgery is excluded.
Key exclusion criteria
Patients without preoperative lumbar CT; patients transferred to another hospital during admission; patients with incomplete medical records; patients with significant structural bone abnormalities due to acute trauma or tumors.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Manzo |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of anesthesiology and Resuscitology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi 470-1192, Japan
TEL
0562-93-2000
manzo@nms.ac.jp
Public contact
Name of contact person
| 1st name | Manzo |
| Middle name | |
| Last name | Suzuki |
Organization
Fujta-Health University
Division name
Department of anesthesiology and Resuscitology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi 470-1192, Japan
TEL
0562-93-2000
Homepage URL
manzo.suzuki@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Ethics commitee Fujita health University
Address
Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi 470-1192, Japan
Tel
0562939610
f-irb@fujita-hu.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
| 2026 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics: Age, sex, BMI, comorbidities (diabetes, hypertension, renal dysfunction), preoperative hemoglobin, coagulation profile, albumin level
Surgical information: Type of surgery, operative time, cardiopulmonary bypass time, intraoperative blood loss, intraoperative transfusion volume (RBC, FFP, platelets), reoperation, postoperative bleeding volume (mediastinal and thoracic drains), postoperative transfusion volume
Imaging data: Preoperative lumbar CT images; mean CT value (HU) at three points of the L3 level; mean CT values at three levels of the sternum
Outcome indicators: Postoperative complications (infection, renal failure, respiratory failure), ICU length of stay, hospital stay, mortality
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071151
