UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Management of vascular access puncture site after percutaneous transluminal angioplasty using calcium alginate sheet
Title of the study (Brief title)	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	Banshodani Masataka
Organization	Tsuchiya General Hospital
Division name	Department of artificial organs
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	Makoto Matsubara
Organization	Tsuchiya General Hospital
Division name	Department of artificial organs
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030958