UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009060 |
|---|---|
| Receipt number | R000010619 |
| Scientific Title | Multicenter prospective cohort study to evaluate the present situation in reference hospitals of Kanagawa prefecture and the efficacy of shonan ruptured abdominal aortic aneurysm protocol for the ruptured abdominal aortic aneurysms |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2012/10/07 16:44:58 |
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Basic information
Public title
Multicenter prospective cohort study to evaluate the present situation in reference hospitals of Kanagawa prefecture and the efficacy of shonan ruptured abdominal aortic aneurysm protocol for the ruptured abdominal aortic aneurysms
Acronym
Multicenter prospective cohort study to evaluate the efficacy of shonan ruptured abdominal aortic aneurysm protocol for the ruptured abdominal aortic aneurysms
Scientific Title
Multicenter prospective cohort study to evaluate the present situation in reference hospitals of Kanagawa prefecture and the efficacy of shonan ruptured abdominal aortic aneurysm protocol for the ruptured abdominal aortic aneurysms
Scientific Title:Acronym
Multicenter prospective cohort study to evaluate the efficacy of shonan ruptured abdominal aortic aneurysm protocol for the ruptured abdominal aortic aneurysms
Region
| Japan |
Condition
Condition
Ruptured abdominal aortic aneurysm
Classification by specialty
| Vascular surgery | Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of shonan ruptured abdominal aortic aneurysm protocol for ruptured abdominal aortic aneurysms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
30-day mortality after the operation
Key secondary outcomes
Length of intensive care unit stay, morbidity, length of hospital stay
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases of ruptured abdominal aortic aneurysm with written informed consent will be included into the study.
Key exclusion criteria
none
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogino Hidemitsu |
Organization
Shonan Kamakura General Hospital
Division name
Department of Surgery
Zip code
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa, 247-8533
TEL
0467-46-1717
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ogino Hidemitsu |
Organization
Shonan Kamakura General Hospital
Division name
Department of Surgery
Zip code
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa, 247-8533
TEL
0467-46-1717
Homepage URL
ohidemitsu@me.com
Sponsor or person
Institute
SRAP study group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
湘南鎌倉総合病院（神奈川県）、平塚市民病院(神奈川県)、済生会横浜市東部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases of ruptured abdominal aortic aneurysm (RAAA) will be treated with either open repair or EVAR according to shonan ruptured abdominal aortic aneurysm protocol (SRAP) to evaluate the efficacy of EVAR and making protocol for treatment of RAAA.
Management information
Registered date
| 2012 | Year | 10 | Month | 07 | Day |
Last modified on
| 2012 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010619
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
