UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032903 |
|---|---|
| Receipt number | R000037517 |
| Scientific Title | 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 12:32:37 |
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Basic information
Public title
Effects of Plasma Exchange on Survival in Patients with Postoperative Liver Failure
Acronym
Effects of Plasma Exchange in Patients with Postoperative Liver Failure
Scientific Title
Effects of Plasma Exchange on Survival in Patients with Postoperative Liver Failure
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshiro Kobe |
Organization
Graduate School of Medicine, Chiba University
Division name
Eastern Chiba Medical Center
Zip code
Address
3-6-2 Okayamadai, Togane, Chiba prefecture
TEL
0475-50-1199
y-kobe@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Kobe |
Organization
Graduate School of Medicine, Chiba University
Division name
Eastern Chiba Medical Center
Zip code
Address
3-6-2 Okayamadai, Togane, Chiba prefecture
TEL
0475-50-1199
Homepage URL
y-kobe@umin.org
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037517
