UMIN-CTR Clinical Trial

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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