UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016568 |
|---|---|
| Receipt number | R000019223 |
| Scientific Title | Retrospective and prospective study for etiology and prognosis of acute liver injury |
| Date of disclosure of the study information | 2015/03/10 |
| Last modified on | 2023/02/23 11:50:48 |
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Basic information
Public title
Retrospective and prospective study for etiology and prognosis of acute liver injury
Acronym
Study for etiology and prognosis of acute liver injury
Scientific Title
Retrospective and prospective study for etiology and prognosis of acute liver injury
Scientific Title:Acronym
Study for etiology and prognosis of acute liver injury
Region
| Japan |
Condition
Condition
Acute liver injury
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To record serial changes of etiology and prognosis of acute liver injury, and to analyse the promoting factors and preventive therapies for the development of hepatic encephalopathy
Basic objectives2
Others
Basic objectives -Others
To record serial changes of etiology and prognosis of acute liver injury, and to analyse the promoting factors and preventive therapies for the development of hepatic encephalopathy
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
coma-developing rate
Key secondary outcomes
survival
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with acute liver injury
Key exclusion criteria
patient who reject to be recruited
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kakisaka |
Organization
Iwate Medical University
Division name
Gastroenterology
Zip code
028-3694
Address
1-1-1idaidori,Yahaba-chou, Shiwa-gun, Iwate Prefecture, 028-3694, Japan
TEL
019-651-5111
keikaki@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | IRB |
| Middle name | |
| Last name | IRB |
Organization
Iwate Medical University
Division name
IRB
Zip code
028-3694
Address
1-1-1idaidori,Yahaba-chou, Shiwa-gun, Iwate Prefecture, 028-3694, Japan
TEL
019-651-5111
Homepage URL
kenkyu-rinri@j.iwate-med.ac.jp
Sponsor or person
Institute
Devision of Gastroenterology
Department of Internal Medicine
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Devision of Gastroenterology
Department of Internal Medicine
Iwate Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Iwate Medical University
Address
1-1-1idaidori,Yahaba-chou, Shiwa-gun, Iwate Prefecture, 028-3694, Japan
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observe and record the etiology, development of coma,
therapies and survival.
Management information
Registered date
| 2015 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019223
