UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030752
Receipt number 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 20:04:03

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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 or person

Institute

Chiba-Nishi General Hospital

Institute

Department

Personal name



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

Value
https://center6.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