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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021660
Receipt No. R000024976
Scientific Title Prevention of hypothermia by pre-warming in living donor liver transplant surgery
Date of disclosure of the study information 2016/04/01
Last modified on 2019/08/05

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Basic information
Public title Prevention of hypothermia by pre-warming in living donor liver transplant surgery
Acronym Pre-warming in living donor liver transplantation
Scientific Title Prevention of hypothermia by pre-warming in living donor liver transplant surgery
Scientific Title:Acronym Pre-warming in living donor liver transplantation
Region
Japan

Condition
Condition Living donor of liver transplantation
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevention effect of perioperative hypothermia by 30-minutes pre-warming in living donor liver transplant surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of perioperative hypothermia occurrence
Key secondary outcomes Transition of core body temperature
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Preoperative 30-minutes warming by 3M Bair Hugger Patient Warming Blanket
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age: =>20 years
2. Living donor of liver transplantation
3. Signed informed consent
Key exclusion criteria 1. History of severe thermal hypersensitivity
2. Decision of the physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoko Sasada
Organization Hiroshima University Hospital
Division name Nursing
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-5530
Email shokora@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoko Sasada
Organization Hiroshima University Hospital
Division name Nursing
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-5530
Homepage URL
Email shokora@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital, Devision of Nursing
Institute
Department

Funding Source
Organization None
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
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 広島大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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
2016 Year 03 Month 17 Day
Date of IRB
2016 Year 03 Month 16 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 29 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024976

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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