UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016821
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015073

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.