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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027386
Receipt No. R000031315
Scientific Title Efficacy of body temperature management during thoracic endovascular aortic repair
Date of disclosure of the study information 2017/05/31
Last modified on 2017/05/18

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Basic information
Public title Efficacy of body temperature management during thoracic endovascular aortic repair
Acronym Body temperature during TEVAR
Scientific Title Efficacy of body temperature management during thoracic endovascular aortic repair
Scientific Title:Acronym Body temperature during TEVAR
Region
Japan

Condition
Condition Stanford type B aortic dissection
Thoracic aortic aneurysm
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our conventional body temperature management during thoracic endovascular aortic repair includes systemic warming using a warming blanket (Bair Hugger (R)). We introduced an additional procedure using a cast padding (ortho-wrap(R)) and a drape equipped with Bair Hugger to maintain lower limb temperature.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of silvering from the start of operation to exit from an operation room
Key secondary outcomes 1, distal temperature at the end of operation
2, central temperature at the end of operation
3, operation time, outcome, duration of hospital stay, complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 with a cast padding and a drape
Interventions/Control_2 without a cast padding and a drape
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, patients undergoing TEVAR for Stanford type B aortic dissection or thoracic aortic aneurysm
2, age more than 20 years old
3, patients obtained informed consent
Key exclusion criteria 1, patients requiring debranch TEVAR (TEVAR with surgical bypass)
2, emergency operation
3, patients with peripheral arterial disease (bilateral or unilateral)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eri Mishima
Organization Hiroshima University Hospital
Division name Surgical operation
Zip code
Address Kasumi.1-2-3,minamiku,Hiroshima,Jpan
TEL 082-257-5530
Email eri-ebi11@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Mishima
Organization Hiroshima University Hospital
Division name Surgical operation
Zip code
Address Kasumi.1-2-3,minamiku,Hiroshima,Japan
TEL 082-257-5530
Homepage URL
Email eri-ebi11@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Department of nursing
Department of operation
Institute
Department

Funding Source
Organization Hiroshima University Hospital
Department of nursing
Department of operation
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 05 Month 31 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 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
2017 Year 05 Month 18 Day
Last modified on
2017 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031315

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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