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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023613
Receipt No. R000024289
Scientific Title Establishment of Hemostatic Protocol and Effectiveness of Alleviating Pain with TR band after Transradial Coronary Catheterization
Date of disclosure of the study information 2016/08/15
Last modified on 2016/08/13

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Basic information
Public title Establishment of Hemostatic Protocol and Effectiveness of Alleviating Pain with TR band after Transradial Coronary Catheterization
Acronym protocol of hemostasis with TR band
Scientific Title Establishment of Hemostatic Protocol and Effectiveness of Alleviating Pain with TR band after Transradial Coronary Catheterization
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichi Ichinose
Organization St Luke's International Hospital
Division name Nursing Department
Zip code
Address 9-1 Akashicho Chuo-ku Tokyo
TEL 03-3541-5151
Email yuichi@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name see above
Organization see above
Division name see above
Zip code
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)

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
2016 Year 08 Month 15 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
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

Other
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

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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