UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicentric survey of acute on chronic liver failure in Japan
Title of the study (Brief title)	Multicentric survey of ACLF in Japan
Region	Japan

Condition
Condition	Acute on chronic liver failure
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the outocme of patients with ACLF seen between 2011 and 2014 retrospectively.
Basic objectives2	Others
Basic objectives -Others	Trend
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	APASL definition of ACLF
Key secondary outcomes	EASL-CLIF consortium definition of ACLF Diagnostic criteria of Chinese Medical Association (CMA)

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	APASL criteria CMA criteria EASL-CLIF Consortium criteria
Key exclusion criteria	APASL criteria CMA criteria EASL-CLIF Consortium criteria
Target sample size	120

Research contact person
Name of lead principal investigator	Satoshi Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Address	Morohongo 38, Moroyama-Machi, Saitama, Japan
TEL	049-2761198
Email	alfsg@saitama-med.ac.jp

Public contact
Name of contact person	Nobuaki Nakayama
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Address	Morohongo 38, Moroyama-Machi, Saitama, Japan
TEL	049-276-1198
Homepage URL
Email	alfsg@saitama-med.ac.jp

Sponsor
Institute	Health Labour Sciences Research Grant, Research on Measures for Intractable Diseases from the Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization	Health Labour Sciences Research Grant, Research on Measures for Intractable Diseases from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 10 Month 23 Day
Anticipated trial start date	2014 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	We conducte a pilot study on ACLF in Japan.

Management information
Registered date	2015 Year 12 Month 22 Day
Last modified on	2018 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023428