UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027386 |
|---|---|
| Receipt number | 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 | 2019/10/31 08:37:51 |
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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
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
eri-ebi11@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of nursing
Department of operation
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
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
| 2019 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031315
