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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027856
Receipt No. R000031917
Scientific Title A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Date of disclosure of the study information 2017/06/21
Last modified on 2017/06/21

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Basic information
Public title A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Acronym A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Scientific Title A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Scientific Title:Acronym A retrospective cohort study on the occurrence of sepsis after blood type incompatibility living liver transplantation
Region
Japan

Condition
Condition A blood type incompatible living liver transplant patient
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the risk factors of postoperative sepsis after ABO-incompatible living liver transplantation at our hospital.
Basic objectives2 Others
Basic objectives -Others Perioperative factors are compared
between septic-onset group and non-sepsis group within 90 days after surgery. In this study, sepsis was referred to "International consensus definition of sepsis and septic shock Third Edition". That is, it was defined as an infection with an increase of 2 or more SOFA scores. Infections were defined based on criteria proposed by centers for disease prevention and prevention and reports on liver transplant related in the past. In addition, sepsis was compared with perioperative factors in the sepsis group and the non-sepsis group by referring to the above guidelines of sepsis, and the risk factors were examined.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Classified the subject cases into septic
onset group and non-onset group, and
compared the perioperative factors in both groups to examine risk factors for sepsis onset.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent ABO-I-LT between November 1997 and March 2016 at our department.
Key exclusion criteria None
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yu Sawada
Organization Yokohama City University
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL 045-787-2650
Email t116036e@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Sawada
Organization Yokohama City University
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL 045-787-2650
Homepage URL
Email t116036e@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization Yokohama City University
Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 Month 21 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective cohort study at a single facility using existing medical record information.

Management information
Registered date
2017 Year 06 Month 21 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031917

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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