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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030752
Receipt No. R000035121
Scientific Title The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Date of disclosure of the study information 2018/01/10
Last modified on 2018/01/10

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Basic information
Public title The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Acronym The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Scientific Title The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Scientific Title:Acronym The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Region
Japan

Condition
Condition Patients with acute aortic dissectionwho admitted to Chiba-Nishi General Hospital
Classification by specialty
Surgery in general Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 TEVAR is being reported as novel teatment option for acute aortic dissection Stanford type B. But there are reports which are saying that TEVAR is related to several complications. On the other hand, conventional conservative teatment also has complications.
We observe dermatitis and phlebitis in the treatment. This study is aimed to evaluate the complication.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phlebitis during the treatment period
Key secondary outcomes The requirement of TEVAR for acute aortic dissection Stanford type B.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria All of the patients who were admitted to Chiba-NIshi General Hospital.
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaki Hori
Organization Chiba-Nishi General Hospital
Division name The department of cardiovascular surgery
Zip code
Address Chiba-Nishi General Hospital, 107-1 Kanegasaku, Matsudo-Shi, Chiba-Ken 2702251, Japan
TEL +81473848111
Email yohei4201@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Kawatani
Organization Chiba-Nishi General Hospital
Division name The department of cardiovascular surgery
Zip code
Address Chiba-Nishi General Hospital, 107-1 Kanegasaku, Matsudo-Shi, Chiba-Ken 2702251, Japan
TEL +81473848111
Homepage URL
Email yohei4201@yahoo.com

Sponsor
Institute Chiba-Nishi General Hospital
Institute
Department

Funding Source
Organization None
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
2018 Year 01 Month 10 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
2014 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 08 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 None

Management information
Registered date
2018 Year 01 Month 10 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035121

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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