UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection
Title of the study (Brief title)	Effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection
Region	Japan

Condition
Condition	Acute aortic dissection
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection at the point of anastomotic leakage to the false lumen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Anastomotic leakage to the false lumen
Key secondary outcomes	Evaluation of effectiveness Intraoperative bleeding Operation time Circuratory arrest time Time for hemostasis Transfusion Maximal diameter of aortic arch at one year after operation Evaluation of safety Operative mortality Stroke, paraplegia, embolization anastomotic lealage,deformation at one year after operation Aortic event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In acsending aortic replacement for acute aortic dissection, we focused on the distal anastomosis. After establishment of extracorporeal circulation and selective cerebral perfusion, we reinforce the dissected distal aortic stump as follows; Bio Glue group We inject Bio Glue to the false lumen under circulatory arrest for five miutes. Thereafter standard aortic stump formation is performed. Interrupted horizontal mattress sutures fix the Teflon felt strips which are placed both side of aortic wall. Then a prosthetic graft is anastomosed by 3-0 porypropyrene sutures.
Interventions/Control_2	Standard method group Interrupted horizontal mattress sutures fix the Teflon felt strips which are placed both side of aortic wall. Then a prosthetic graft is anastomosed by 3-0 porypropyrene sutures.
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	Emergent surgery for Stanford type A acute aortic dissection (1)all age, male and female (2)dissection extend to descending aorta (3)Patients' consent
Key exclusion criteria	inappropriate patients depend on doctor's judgement
Target sample size	80

Research contact person
Name of lead principal investigator	Keiji Uchida
Organization	Yokohama City University Medical Center
Division name	cardiovascular surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	uchida@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Keiji Uchida
Organization	Yokohama City University Medical Center
Division name	cardiovascular surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	uchida@urahp.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 10 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 23 Day
Last modified on	2017 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008927