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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024202
Receipt No. R000027828
Scientific Title The Study of Tranexamic Acid suppression fibrinolysis for Endoleak before Endovascular Repair for Aortic Aneurysm
Date of disclosure of the study information 2016/09/30
Last modified on 2018/06/11

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Basic information
Public title The Study of Tranexamic Acid suppression fibrinolysis for Endoleak before Endovascular Repair for Aortic Aneurysm
Acronym The Study of Tranexamic Acid for Endoleak before Endovascular Repair for Aortic Aneurysm
Scientific Title The Study of Tranexamic Acid suppression fibrinolysis for Endoleak before Endovascular Repair for Aortic Aneurysm
Scientific Title:Acronym The Study of Tranexamic Acid for Endoleak before Endovascular Repair for Aortic Aneurysm
Region
Japan

Condition
Condition Aortic aneurysma
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the endoleak controal effect of the tranexamic acid before stentgraft treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (enhanced) CT and US view, 1month, 3month, 6month, 1to5years after operation
Key secondary outcomes labo data (especially D-dimer)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are added the Tranexamic acid(1500mg/day) for 30days just before stentgraft treatment.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Aortic aneurysms patients with indication for stentgraft implantation
Key exclusion criteria aneurysms patients without indication for stentgraft implantation
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Oozawa
Organization Okayama University Hospital
Division name Cardiovascular surgery
Zip code
Address 2-5-1, Shikata-cho, Kita, Okayama
TEL +81-86-235-7359
Email ohzawa-s@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Oozawa
Organization Okayama University Hospital
Division name Cardiovascular surgery
Zip code
Address 2-5-1, Shikata-cho, Kita, Okayama
TEL +81-86-235-7359
Homepage URL
Email ohzawa-s@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Okayama University Hospital
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 09 Month 30 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 Terminated
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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
2016 Year 09 Month 28 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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