UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022379 |
|---|---|
| Receipt number | R000025596 |
| Scientific Title | Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/05/20 12:45:59 |
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Basic information
Public title
Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft
Acronym
Usage of rifampicin-bonded gelatin-sealed Dacron graft
Scientific Title
Treatment of infected aortic aneurysm or vascular graft infection with a rifampicin-bonded gelatin-sealed Dacron graft
Scientific Title:Acronym
Usage of rifampicin-bonded gelatin-sealed Dacron graft
Region
| Japan |
Condition
Condition
infected aortic aneurysm, vascular graft infection
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
anatomical reconstruction of artery after resection of infected aortic aneurysm or infected vascular graft
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical control of infection (imaging study and/or laboratory study)
Key secondary outcomes
patient death
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
gelatin-sealed Dacron graft is soaked in rifampicin 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 infectious aortic aneurysm or vascular graft infection diagnosed by imaging study and/or laboratory study
(2) patients with refractory to medical treatment
Key exclusion criteria
(1) patients with allergic for rifampicin
(2) patients who refuse to the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiich Kanda |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular Surgery
Zip code
Address
465 Kajii-cho, Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL
0752515752
kei@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiich Kanda |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular Surgery
Zip code
Address
465 Kajii-cho, Kawaramachi, Hirokoji, Kamigyo-ku, Kyoto
TEL
0752515752
Homepage URL
kei@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
none
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 | 07 | Month | 01 | 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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025596
