UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053348 |
|---|---|
| Receipt number | R000060783 |
| Scientific Title | Four-Group Classification Based on Fibrinogen Level and Dielectric Blood Coagulation Test Associated with Post-Cardiac Surgery Hemorrhage: a single-center retrospective observational study |
| Date of disclosure of the study information | 2024/01/14 |
| Last modified on | 2025/11/11 10:58:17 |
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Basic information
Public title
Four-Group Classification Based on Fibrinogen Level and Dielectric Blood Coagulation Test Associated with Post-Cardiac Surgery Hemorrhage: a single-center retrospective observational study
Acronym
Four-Group Classification Based on Fibrinogen Level and Dielectric Blood Coagulation Test Associated with Post-Cardiac Surgery Hemorrhage: a single-center retrospective observational study
Scientific Title
Four-Group Classification Based on Fibrinogen Level and Dielectric Blood Coagulation Test Associated with Post-Cardiac Surgery Hemorrhage: a single-center retrospective observational study
Scientific Title:Acronym
Four-Group Classification Based on Fibrinogen Level and Dielectric Blood Coagulation Test Associated with Post-Cardiac Surgery Hemorrhage: a single-center retrospective observational study
Region
| Japan |
Condition
Condition
Cardiovascular surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the hypothesis that the combined assessment of plasma fibrinogen levels and the Spotchem test is associated with postoperative thoracic drain bleeding.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative thoracic drain bleeding
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent cardiovascular surgery using cardiopulmonary bypass at Hamamatsu Medical University Hospital from February 2020 to April 2021.
Key exclusion criteria
Incomplete data collecting, re-cardiopulmonary bypass connection
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University Hospital
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL
0534352738
suzukiy@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL
0534352738
Homepage URL
suzukiy@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Yuji Suzuki
Funding Source
Organization
Self funding
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 Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2024 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
174
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
Main results already published
Date of protocol fixation
| 2024 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special note
Management information
Registered date
| 2024 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060783
