UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Study of Tranexamic Acid suppression fibrinolysis for Endoleak before Endovascular Repair for Aortic Aneurysm
Title of the study (Brief title)	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	Susumu Oozawa
Organization	Okayama University Hospital
Division name	Cardiovascular surgery
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	Susumu Oozawa
Organization	Okayama University Hospital
Division name	Cardiovascular surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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