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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032903
Receipt No. R000037517
Official scientific title of the study Effects of Plasma Exchange on Survival in Patients with Postoperative Liver Failure
Date of disclosure of the study information 2018/06/07
Last modified on 2018/06/07

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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

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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