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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007558
Receipt No. R000008927
Scientific Title Effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection
Date of disclosure of the study information 2012/03/23
Last modified on 2017/10/02

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Basic information
Public title Effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection
Acronym Effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection
Scientific Title Effectiveness of Bio Glue in reinforcing the aortic stump of acute aortic dissection
Scientific Title:Acronym 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
1st name
Middle name
Last name Keiji Uchida
Organization Yokohama City University Medical Center
Division name cardiovascular surgery
Zip code
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
1st name
Middle name
Last name Keiji Uchida
Organization Yokohama City University Medical Center
Division name cardiovascular surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 01 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000008927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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