UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056633 |
|---|---|
| Receipt number | R000064714 |
| Scientific Title | Radial Artery Patency by an Individual-optimizeD Hemostasis Protocol: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2026/02/15 19:02:37 |
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Basic information
Public title
Radial Artery Patency by an Individual-optimizeD Hemostasis Protocol: A Randomized Controlled Trial
Acronym
RAPID-Hemostasis
Scientific Title
Radial Artery Patency by an Individual-optimizeD Hemostasis Protocol: A Randomized Controlled Trial
Scientific Title:Acronym
RAPID-Hemostasis
Region
| Japan |
Condition
Condition
Ischemic artery disease
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of different hemostasis methods on radial artery patency after transradial percutaneous coronary intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Radial artery patency 3 months after PCI
Key secondary outcomes
Hemostasis completion time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Early decompression protocol
(Using the TR Band, 16 ml of air is injected initially. Subsequently, air is slowly released every 30 minutes until slight bleeding is observed, at which point 2 ml of air is reinjected. The process is considered complete once all air is removed.)
Interventions/Control_2
Traditional protocol
(Using the TR Band, 16 ml of air is injected initially. After 10 minutes, 2 ml is removed, followed by the removal of 4 ml after 4 hours, and then 10 ml after an additional hour, provided there is no bleeding. If bleeding occurs, half the volume of the removed air is reinjected.)
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
Patients undergoing PCI via the radial artery approach
Patients who can undergo vascular ultrasound examination before and after the PCI
Key exclusion criteria
Known contraindications for PCI (e.g., severe allergic reactions, refractory comorbid conditions)
Patients deemed unsuitable for study participation by the attending physician
Target sample size
254
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hirohata |
Organization
The Sakakibara Hert Institute of Okayama
Division name
Department of Cardiology
Zip code
7000804
Address
2-5-1 Nakai-cho Kita-ku, Okayama JAPAN
TEL
0862257111
hirohata@tg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Takamatsu |
Organization
The Sakakibara Hert Institute of Okayama
Division name
Department of Nursing
Zip code
7000804
Address
2-5-1 Nakai-cho Kita-ku, Okayama JAPAN
TEL
0862257111
Homepage URL
nonnonsamamomo@yahoo.co.jp
Sponsor or person
Institute
The Sakakibara Hert Institute of Okayama
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Ethics Committee of Sakakibara Hert institute of Okayama
Address
2-5-1 Nakai-cho Kita-ku, Okayama 700-0804 JAPAN
Tel
0862257111
kango@sakakibara-hp.com
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
| 2025 | Year | 01 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064714
