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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019858
Receipt No. R000022021
Scientific Title Thermal effect of air warmer blanket on donor of living liver transplantation
Date of disclosure of the study information 2015/11/22
Last modified on 2016/01/06

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Basic information
Public title Thermal effect of air warmer blanket on donor of living liver transplantation
Acronym Thermal effect of air warmer blanket on donor of living liver transplantation
Scientific Title Thermal effect of air warmer blanket on donor of living liver transplantation
Scientific Title:Acronym Thermal effect of air warmer blanket on donor of living liver transplantation
Region
Japan

Condition
Condition Donor of living liver transplantation
Classification by specialty
Surgery in general Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the difference of thermal effect between air warmer blankets on donor of living liver transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of thermal effect between upper-type air warmer blanket and under-type blanket.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We warm patients by upper body type blanlet(3M Bair Hugger Temperature Management Blanket Upper Body Model 52200), and we measure distal esophageal temparature as core tenparature (cetral temparature).
Intervention period is during patient is in the operation room.
Interventions/Control_2 We warm patients by under body type blanlet(3M Bair Hugger Temperature Management Blanket Lithotomy Underbody Model 58501), and we measure distal esophageal temparature as core tenparature (cetral temparature).
Intervention period is during patient is in the operation room.
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 Patient who is 20 years and older.
Patient who can understand the the research program fully.
Patient who can assume and agree.
Key exclusion criteria Patient who underwent emergency surgery.
Consent has been revoked.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Hoka
Organization Kyushu University
Division name Department of anesthesiology and critical care medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL 092-642-5714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Hayamizu
Organization Kyushu University hospital
Division name Department of surgery
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL 092-642-5714
Homepage URL
Email hayamizu.kengo.906@m.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Department of anesthesiology and critical care medicine
Institute
Department

Funding Source
Organization none
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 22 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 19 Day
Last modified on
2016 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022021

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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