UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007558 |
|---|---|
| Receipt number | 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 09:02:48 |
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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
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
uchida@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008927
