UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021660 |
|---|---|
| Receipt number | 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 00:14:57 |
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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
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
shokora@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital, Devision of Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024976
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
