UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017412 |
|---|---|
| Receipt number | R000020196 |
| Scientific Title | Relationship between cardiopulmonary bypass time, platelet count and bleeding amount during cardiovascular surgery |
| Date of disclosure of the study information | 2015/05/05 |
| Last modified on | 2020/09/11 08:06:47 |
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Basic information
Public title
Relationship between cardiopulmonary bypass time, platelet count and bleeding amount during cardiovascular surgery
Acronym
A new strategy of transfusion for cardiovascular operation
Scientific Title
Relationship between cardiopulmonary bypass time, platelet count and bleeding amount during cardiovascular surgery
Scientific Title:Acronym
The longer CPB time, the more bleeding amount during cardiac surgery
Region
| Japan |
Condition
Condition
Cardiovascular operation using cardioplumonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare total amount of blood transfusion and bleeding divided by CPB time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total amount of blood transfusion and 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elective cardiovascular operation using cardioplumonary bypass
Key exclusion criteria
The patients we cannot get the informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Kodaka |
Organization
Tokyo women's medical university medical center east
Division name
Anesthesiology
Zip code
116-8567
Address
2-1-10 Nishi-ogu Arakawaku Tokyo
TEL
03-3810-1111
kmkodaka@cb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | MITSHARU |
| Middle name | |
| Last name | KODAKA |
Organization
TOKYO WOMEN'S MEDICAL UNIVERSITY
Division name
ANESTHESIOLOGY
Zip code
116-8567
Address
2-1-10 NISHI-OGU ARAKAWAKU TOKYO
TEL
09022047740
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
TOKYO WOMEN'S MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
KAKEN fund from public health and labor ministry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TOKYO WOMEN'S MEDICAL UNIVERSITY
Address
2-1-10 NISHI-OGU ARAKAWAKU TOKYO
Tel
+819022047740
manachan048777@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
150208
Org. issuing International ID_1
TOKYO WOMEN'S MEDICAL UNIVERSITY
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
160
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
| 2015 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observatory study
Management information
Registered date
| 2015 | Year | 05 | Month | 04 | Day |
Last modified on
| 2020 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020196
