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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016568
Receipt No. 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 2018/08/20

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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
Middle name
Last name Yasuhiro Takikawa
Organization Iwate Medical University
Division name Hepatology
Zip code
Address 19-1 Uchimaru, Morioka, Japan
TEL 019-651-5111
Email ytakikaw@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name IRB
Organization Iwate Medical University
Division name IRB
Zip code
Address 19-1 Uchimaru, Morioka, Japan
TEL 019-651-5111
Homepage URL
Email kenkyu-rinri@j.iwate-med.ac.jp

Sponsor
Institute Devision of Hepatology
Department of Internal Medicine
Iwate medical University
Institute
Department

Funding Source
Organization Devision of Hepatology
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
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

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
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019223

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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