UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022436 |
|---|---|
| Receipt number | R000025856 |
| Scientific Title | The study of spinal cord protection in TEVAR to thoracic aortic disease |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2020/07/01 13:48:08 |
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Basic information
Public title
The study of spinal cord protection in TEVAR to thoracic aortic disease
Acronym
The study of spinal cord protection in TEVAR
Scientific Title
The study of spinal cord protection in TEVAR to thoracic aortic disease
Scientific Title:Acronym
The study of spinal cord protection in TEVAR
Region
| Japan |
Condition
Condition
Thoracic aortic disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of preoperative ischemic preconditioning for spinal cord injury after TEVAR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of spinal cord paraplegia (Tarlov scale)
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
IPC group: standard surgery plus four 5 minute inflations (200 mm Hg, but at least 15 mm Hg higher than the actual systolic arterial pressure) and deflations of a standard blood pressure cuff on the upper arm
Interventions/Control_2
Control group: standard surgery
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 with thoracic aortic disease (aneurysm, dissection).
2)Patients with age 20.
3)Regardless of gender.
4)Patients can provide written informed consent for study participation.
Key exclusion criteria
1)Patients in need of emergency surgery (rupture or impending rupture)
2)Patients determined to be ineligible for this clinical study by research attending physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2261
kimikazu@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Samura |
Organization
Yamaguchi University Hospital
Division name
Department of Surgery and Clinical Science
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2261
Homepage URL
m.samura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 24 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025856
