UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015986 |
|---|---|
| Receipt number | R000018593 |
| Scientific Title | RCT(randomized control trial) for effectiveness of Tranexamic acid for type II endoleak after endovascular aneurysm repair |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2018/12/20 09:19:40 |
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Basic information
Public title
RCT(randomized control trial) for effectiveness of Tranexamic acid for type II endoleak after endovascular aneurysm repair
Acronym
Tranexamic acid for type II endoleak
Scientific Title
RCT(randomized control trial) for effectiveness of Tranexamic acid for type II endoleak after endovascular aneurysm repair
Scientific Title:Acronym
Tranexamic acid for type II endoleak
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the reducing effect for type II endoleak in Tranexamic acid after EVAR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of type II endoleak after EVAR (Number of patients)
Key secondary outcomes
1 Changing aneurysm size
2 Frequency of re-intervention
3 Biomarker
MMP-9
IFN-r
IL-6
D-dimer
FDP
PAI-1
TGF-B
PIC
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tranexamic acid 750 mg/day for 6 months after EVAR
Interventions/Control_2
Non-administration of Tranexamic acid
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
EVAR cases for Abdominal aortic aneurysm Consent cases for this study
Key exclusion criteria
Rupture cases
History of thrombosis
Allergy for Tranexamic acid
Impossible for follow up
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Kato |
Organization
Morinomiya Hospital
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
2-1-88 Morinomiya Joutou-ku Osaka 536-0025 Japan
TEL
06-6969-0111
mkato3@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Kato |
Organization
Morinomiya Hospital
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
2-1-88 Morinomiya Joutou-ku Osaka 536-0025 Japan
TEL
06-6969-0111
Homepage URL
mkato3@gmail.com
Sponsor or person
Institute
Morinomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
森之宮病院(大阪府） Morinomiya Hospital(Osaka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018593
