UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027022 |
|---|---|
| Receipt number | R000030958 |
| Scientific Title | Management of vascular access puncture site after percutaneous transluminal angioplasty using calcium alginate sheet |
| Date of disclosure of the study information | 2017/04/17 |
| Last modified on | 2018/04/27 23:08:33 |
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Basic information
Public title
Management of vascular access puncture site after percutaneous transluminal angioplasty using calcium alginate sheet
Acronym
Comparative examination of hemostatic sheet after percutaneous transluminal angioplasty
Scientific Title
Management of vascular access puncture site after percutaneous transluminal angioplasty using calcium alginate sheet
Scientific Title:Acronym
Comparative examination of hemostatic sheet after percutaneous transluminal angioplasty
Region
| Japan |
Condition
Condition
Vascular access failure
Classification by specialty
| Nephrology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of a hemostatic wound dressing made of a calcium alginate at puncture sites of vascular access after percutaneous transluminal angioplasty, and to evaluate other factors affecting on hemostasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of "time to hemostatsis" (5, 10, 15, and >15 minutes) at the puncture sites after PTA in each group.
Key secondary outcomes
Safety (confirmation of complications)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We use the calcium alginate sheet to achieve hemostasis.
Interventions/Control_2
We use the non-drug sheet to achieve hemostasis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients of 250 cases who undergo PTA in Tsuchiya General Hospital from
November 1, 2016.
Key exclusion criteria
Patients who did not consent to this study, were punctured with respect to arteries, were used more than three sheaths, and had hematoma at the puncture site during PTA.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Banshodani Masataka |
Organization
Tsuchiya General Hospital
Division name
Department of artificial organs
Zip code
Address
3-30, Nakajimacho, Naka-ku, Hiroshima, 730-8655, Japan
TEL
082-243-9191
mban1127@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Matsubara |
Organization
Tsuchiya General Hospital
Division name
Department of artificial organs
Zip code
Address
3-30, Nakajimacho, Naka-ku, Hiroshima, 730-8655, Japan
TEL
082-243-9191
Homepage URL
white_jack0070@yahoo.co.jp
Sponsor or person
Institute
Tsuchiya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuchiya General Hospital
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
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
| 2017 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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
| 2017 | Year | 04 | Month | 17 | Day |
Last modified on
| 2018 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030958
