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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027022
Receipt No. 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

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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
Email 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
Email white_jack0070@yahoo.co.jp

Sponsor
Institute Tsuchiya General Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030958

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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