UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015722 |
|---|---|
| Receipt number | R000018279 |
| Scientific Title | Efficacy and Safety of intra-aortic balloon occlusion: observational study |
| Date of disclosure of the study information | 2014/11/19 |
| Last modified on | 2017/05/22 10:00:08 |
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Basic information
Public title
Efficacy and Safety of intra-aortic balloon occlusion: observational study
Acronym
IABO registry
Scientific Title
Efficacy and Safety of intra-aortic balloon occlusion: observational study
Scientific Title:Acronym
IABO registry
Region
| Japan |
Condition
Condition
hemorrhagic shock, elective surgery with high risk of bleeding
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observation for efficacy and safety of IABO by registration in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in central blood pressure after inflation of IABO
Key secondary outcomes
Safety during using IABO
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All IABO cases
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Oda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo, Chiba city
TEL
043-222-7171
odas@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Matsumura |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo, Chiba city
TEL
043-222-7171
Homepage URL
yousuke.jpn4035@gmail.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28328730
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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
1.Patients ID, sex, height, weight, complication, past history
2.IABO catheter type
3.Indication; hemorrhagic shock(abdomen, pelvis or retroperitoneum), elective surgery with high risk of bleeding
4.Efficacy: Changes in central blood pressure after inflation of IABO
5.Safety: Ischemia (leg, spine, bowel, kidney, liver, spleen)
Management information
Registered date
| 2014 | Year | 11 | Month | 19 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/05/22 | 28328730.pdf |
