UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of Hemostatic Protocol and Effectiveness of Alleviating Pain with TR band after Transradial Coronary Catheterization
Title of the study (Brief title)	protocol of hemostasis with TR band
Region	Japan

Condition
Condition	Angina Pectoris
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the previous study, decreasing pressure of TR band is proved of safe hemostasis. Purpose of this study is to prove the safety of hemostasis by nurses and to alleviate pain by using the hemostasis protocol from the previous study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hemostatis by using TR band
Key secondary outcomes	to alleviate pain

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	decompress TR band by nurses with the protocol
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	person who is over 20 years old radial artery approach on coronary angiography or percutaneous intervention
Key exclusion criteria	Unconscious patient who is not be able to sign the consent Use sheath other than 4Fr, 5Fr or 6Fr patient who cannot palpate radial artery Negative Allen test platelets less than 50,000/ul coagulation problems without any anticoagulant medications
Target sample size	400

Research contact person
Name of lead principal investigator	Yuichi Ichinose
Organization	St Luke's International Hospital
Division name	Nursing Department
Address	9-1 Akashicho Chuo-ku Tokyo
TEL	03-3541-5151
Email	yuichi@luke.ac.jp

Public contact
Name of contact person	see above
Organization	see above
Division name	see above
Address	see above
TEL	03-3541-5151
Homepage URL
Email	yuichi@luke.ac.jp

Sponsor
Institute	St Luke's International Hospital
Institute
Department

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)

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 08 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 15 Day
Anticipated trial start date	2016 Year 03 Month 15 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	2016 Year 08 Month 13 Day
Last modified on	2016 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024289