UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023613 |
|---|---|
| Receipt number | 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 02:53:33 |
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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
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
yuichi@luke.ac.jp
Sponsor or person
Institute
St Luke's International Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024289
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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