UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016821 |
|---|---|
| Receipt number | R000015073 |
| Scientific Title | The efficacy of tranexamic acid for fibrinolytic system after cesarean section by ROTEMTM |
| Date of disclosure of the study information | 2015/03/17 |
| Last modified on | 2015/03/17 16:28:04 |
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Basic information
Public title
The efficacy of tranexamic acid for fibrinolytic system after cesarean section by ROTEMTM
Acronym
The efficacy of tranexamic acid for fibrinolytic system after cesarean section by ROTEMTM
Scientific Title
The efficacy of tranexamic acid for fibrinolytic system after cesarean section by ROTEMTM
Scientific Title:Acronym
The efficacy of tranexamic acid for fibrinolytic system after cesarean section by ROTEMTM
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We administer tranexam acid for the patients after cesareab section due to fiblynosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the ratio of fiblinosis after cesearian section and correct dose of tranexiam acid
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Cesearian section which bleeding =<2L
Interventions/Control_2
Cesearian section which bleeding >2L
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Scheduled cesearian section
Key exclusion criteria
Bleeding tendency
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Komori |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
Address
2-1-10 Nishiogu Arakawaku Tokyo
TEL
03-3810-1111
mkomori@ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuharu Kodaka |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
Address
2-1-10 Nishiogu Arakawaku Tokyo
TEL
03-3810-1111
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 03 | Month | 17 | 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
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 17 | Day |
Last modified on
| 2015 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015073
