UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039337 |
|---|---|
| Receipt number | R000044864 |
| Scientific Title | Effect of rotational thromboelastometry on mortality and bleeding outcome in cardiovascular surgery: A cohort Study |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2020/01/31 12:31:27 |
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Basic information
Public title
Effect of rotational thromboelastometry on mortality and bleeding outcome in cardiovascular surgery: A cohort Study
Acronym
Thromboelastometry and clinical outcomes
Scientific Title
Effect of rotational thromboelastometry on mortality and bleeding outcome in cardiovascular surgery: A cohort Study
Scientific Title:Acronym
Thromboelastometry and clinical outcomes
Region
| Japan |
Condition
Condition
The study was completed
Classification by specialty
| Chest surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical importance of hemostatic assessment with a viscoelastic device in cardiovascular surgery remains unclear. This study aimed to determine whether a blood transfusion protocol with rotational thromboelastometry could reduce mortality, bleeding complication, and blood transfusion rates in cardiac surgery or thoracic aortic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause mortality, re-exploration for bleeding, major bleeding
Key secondary outcomes
Blood transfusion rate
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
A cohort of consecutive cardiovascular surgery patients with Cardiopulmonary bypass.
Key exclusion criteria
No exclusion criteria were used in this study.
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Mutsuhito |
| Middle name | |
| Last name | Kikura |
Organization
Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Division name
Department of Anesthesiology
Zip code
430-8525
Address
25 Shogen-cho, Higashi-ku, Hamamatsu 430-8525, Japan
TEL
++81-53-462-1211
mkikura@hotmail.com
Public contact
Name of contact person
| 1st name | Mutsuhito |
| Middle name | |
| Last name | Kikura |
Organization
Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Division name
Department of Anesthesiology
Zip code
430-8525
Address
25 Shogen-cho, Higashi-ku, Hamamatsu 430-8525, Japan
TEL
++81-53-462-1211
Homepage URL
mkikura@hotmail.com
Sponsor or person
Institute
Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Rosai Hospital, Japan Organization of Occupational Health and Safety
Address
25 Shogen-cho, Higashi-ku, Hamamatsu 430-8525, Japan
Tel
++81-53-462-1211
soumuka@hamamatsuh.johas.go.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 | 01 | Month | 31 | 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
370
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively studied a cohort of 376 consecutive patients who underwent cardiopulmonary bypass before (control group: 150 cardiac and 35 thoracic aortic surgeries) and after (assessment group: 154 cardiac and 37 thoracic aortic surgeries) introducing the point-of-care assessment with thromboelastometry in the blood transfusion protocol. We compared the difference in all-cause mortality, re-exploration for bleeding, major bleeding, and blood transfusion rate between the control and assessment groups.
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044864
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
