UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041965 |
|---|---|
| Receipt number | R000047903 |
| Scientific Title | Retrospective study to identify prognostic factor for the patients with acute liver injury |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/10/01 16:50:09 |
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Basic information
Public title
Retrospective study to identify prognostic factor for the patients with acute liver injury
Acronym
Prognostic factor for the patients with acute liver injury
Scientific Title
Retrospective study to identify prognostic factor for the patients with acute liver injury
Scientific Title:Acronym
Prognostic factor for the patients with 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 identify the prognostic factor of the patients with acute liver injury
Basic objectives2
Others
Basic objectives -Others
Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deceased
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute liver injury
Key exclusion criteria
The subjects who do not wish to participate or are considered as ineligible by the attending physician.
Target sample size
312
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takikawa |
Organization
Iwate medical university
Division name
Department of internal medicine, Division of Hepatology
Zip code
028-3694
Address
Idaidori 1-1-1, Yahaba cho, Iwate
TEL
019-651-5111
ytakikaw@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | Kakisaka |
| Last name | Kakisaka |
Organization
Iwate medical university
Division name
Department of internal medicine, Division of Hepatology
Zip code
028-3028
Address
Idaidori 1-1-1, Yahaba cho, Iwate
TEL
0196515111
Homepage URL
keikaki@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university
Institute
Department
Personal name
Funding Source
Organization
Iwate medical university
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
IRB of Iwate medical university, school of medicine
Address
Idaidori 1-1-1, Yahaba cho, Iwate
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
| 2020 | Year | 10 | Month | 01 | 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
312
Results
Among the 312 patients with acute liver injury, the patients who progressed to acute liver failure (ALF) revealed poor prognosis. In these patients, autoimmune hepatitis or oral infected viral hepatitis showed good prognosis. In contrast, drug-induced liver injury or HBV carrier had a poor prognosis.
Results date posted
| 2020 | Year | 10 | Month | 01 | Day |
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
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since this is a retrospective study, date of protocol fixation and last follow-up date are the same date.
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047903
| 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 |
