UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061939 |
|---|---|
| Receipt number | R000070862 |
| Scientific Title | Association of Fibrinogen Levels and Platelet Counts Immediately After Separation From Cardiopulmonary Bypass With Time to Surgical Completion: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/17 09:07:02 |
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Basic information
Public title
Association of Fibrinogen Levels and Platelet Counts Immediately After Separation From Cardiopulmonary Bypass With Time to Surgical Completion: A Retrospective Cohort Study
Acronym
Association of Fibrinogen Levels and Platelet Counts Immediately After Separation From Cardiopulmonary Bypass With Time to Surgical Completion: A Retrospective Cohort Study
Scientific Title
Association of Fibrinogen Levels and Platelet Counts Immediately After Separation From Cardiopulmonary Bypass With Time to Surgical Completion: A Retrospective Cohort Study
Scientific Title:Acronym
Association of Fibrinogen Levels and Platelet Counts Immediately After Separation From Cardiopulmonary Bypass With Time to Surgical Completion: A Retrospective Cohort Study
Region
| Japan |
Condition
Condition
Cardiovascular surgery requiring cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether fibrinogen levels and platelet counts measured immediately after separation from cardiopulmonary bypass are associated with time to surgical completion. The association between these hemostatic parameters and post-bypass blood loss will also be investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from separation from cardiopulmonary bypass to surgical completion (minutes)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing cardiovascular surgery with cardiopulmonary bypass through a median sternotomy.
Patients in whom both fibrinogen level and platelet count were measured within 30 minutes after separation from cardiopulmonary bypass.
Key exclusion criteria
1. Patients who required reinstitution of cardiopulmonary bypass during the same surgical procedure (second pump run).
2. Patients with missing data for the primary explanatory variables, including fibrinogen level or platelet count measured immediately after separation from cardiopulmonary bypass.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yashiro |
| Middle name | |
| Last name | Suda |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
0788510
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan.
TEL
0166682583
suda0223@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suda |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
0788510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan.
TEL
0166682583
Homepage URL
suda0223@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Yasuhiro Suda
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan.
Tel
0166682583
suda0223@asahikawa-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
| 2026 | Year | 06 | Month | 17 | 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 | 04 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational cohort study using routinely collected clinical data. The study will evaluate the associations of fibrinogen level and platelet count measured immediately after separation from cardiopulmonary bypass with time to surgical completion and post-bypass blood loss in adult patients undergoing cardiovascular surgery with cardiopulmonary bypass.
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070862
