UMIN-CTR Clinical Trial

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
Email	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
Email	m.samura@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine Department of Surgery and Clinical Science
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025856