UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012885
Receipt number R000014697
Scientific Title Effectiveness of rifampicin-soaked vascular graft as an treatment for infective aneurysm
Date of disclosure of the study information 2014/01/17
Last modified on 2014/01/17 14:53:20

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Basic information

Public title

Effectiveness of rifampicin-soaked vascular graft as an treatment for infective aneurysm

Acronym

Effectiveness of rifampicin-soaked vascular graft as an treatment for infective aneurysm

Scientific Title

Effectiveness of rifampicin-soaked vascular graft as an treatment for infective aneurysm

Scientific Title:Acronym

Effectiveness of rifampicin-soaked vascular graft as an treatment for infective aneurysm

Region

Japan


Condition

Condition

Infective aortic aneurysm

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the effectiveness of rifampicin-soaked vascular graft in patients with infective aortic aneurysm.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

clinical control of infection, operative death

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

vascular graft is soaked in rifampin solution before implantation

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) patients with infective aortic aneurysm diagnosed with imaging study and/or laboratory study
(2) refractory to medical treatment

Key exclusion criteria

(1)age younger than 20 years
(2)patients with allgery to rifampicin
(3) patients who refuse to the study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Minakata

Organization

Kyoto University Graduate School of Medicine

Division name

Cardiovascular Surgery

Zip code


Address

54 Kawahara-cho Shogoin, Sakyoku, Kyoto

TEL

075-751-3780

Email

minakata@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Minakata

Organization

Kyoto University Graduate School of Medicine

Division name

Cardiovascular Surgery

Zip code


Address

54 Kawaharacho, Shogoin, Sakyoku, Kyoto

TEL

075-751-3780

Homepage URL


Email

minakata@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto University Graduate School of Medicine

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

京都大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 17 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

Enrolling by invitation

Date of protocol fixation

2014 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 17 Day

Last modified on

2014 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name