UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Plasma Exchange on Survival in Patients with Postoperative Liver Failure
Title of the study (Brief title)	Effects of Plasma Exchange in Patients with Postoperative Liver Failure
Region	Japan

Condition
Condition	Postoperative hepatic failure
Classification by specialty	Gastroenterology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Postoperative hepatic failure (POLF) syndrome is recently decreased by the progress of surgical techniques, critical care, and postoperative treatment. However, management of POLF still remains a challenge and when it worsens, it turns to be a significant source of morbidity and mortality. Plasma exchange (PE) is used as a salvage strategy for POLF in some countries, especially in Japan. Several authors have reported the usefulness of PE for POLF syndrome, which were conducted in 1990 to 2000. We conducted retrospective single center study to investigate effects of patients with POLF treated with PE.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SOFA score
Key secondary outcomes	patient outcomes, Glasgow Coma Scale (GCS), prothrombin time, serum total bilirubin level

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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects of this study were included patients with postoperative liver failure who admitted to the ICU and were performed with PE. The definition of postoperative liver failure was persistent hyperbilirubinemia.
Key exclusion criteria	Under 20 year old
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshiro Kobe
Organization	Graduate School of Medicine, Chiba University
Division name	Eastern Chiba Medical Center
Address	3-6-2 Okayamadai, Togane, Chiba prefecture
TEL	0475-50-1199
Email	y-kobe@umin.org

Public contact
Name of contact person	Yoshiro Kobe
Organization	Graduate School of Medicine, Chiba University
Division name	Eastern Chiba Medical Center
Address	3-6-2 Okayamadai, Togane, Chiba prefecture
TEL	0475-50-1199
Homepage URL
Email	y-kobe@umin.org

Sponsor
Institute	Chiba university
Institute
Department

Funding Source
Organization	Chiba university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2018 Year 06 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 06 Month 01 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	Unpublished
URL releasing results
Results
Other related information	The study was already finished.

Management information
Registered date	2018 Year 06 Month 07 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037517