UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Emergency surgery for acute type A aortic dissection in octogenarians without patient selection.
Title of the study (Brief title)	ACUTE TYPA A SRUGERY IN OCTOGENARIANS
Region	Japan

Condition
Condition	acute type A aortic dissection
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Octogenarians are often declined emergent surgery for acute type A aortic dissection on grounds of high mortality rate and short life expectancy. Our policy is to accept all patients at any time and never to refuse an emergency operation, even for octogenarians.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hospital death
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	32 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	operation
Key exclusion criteria	none
Target sample size	319

Research contact person
Name of lead principal investigator	Tomoaki Suzuki
Organization	Shiga university of medical science
Division name	cardiovascular surgery
Address	setatsukinowa
TEL	0775482244
Email	suzukit@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hiromu Kutsumi
Organization	Shiga university of medical science
Division name	Shiga university of medical science
Address	setatsukinowa
TEL	0775482244
Homepage URL
Email	hqrinken@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga university of medical science
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2018 Year 03 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 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	none

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2018 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036336