UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024202 |
|---|---|
| Receipt number | 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 13:27:18 |
* 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 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
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
ohzawa-s@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027828
