UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046919 |
|---|---|
| Receipt number | R000053518 |
| Scientific Title | A cohort study of arrhythmia screening in apheresis donors by analyzing fingertip pulse wave |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/08/20 14:05:22 |
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Basic information
Public title
Arrhythmia screening by using pulse oximeter
Acronym
Easy health check by fingertip device
Scientific Title
A cohort study of arrhythmia screening in apheresis donors by analyzing fingertip pulse wave
Scientific Title:Acronym
Arrhythmia screening trial by using pulse oximeter
Region
| Japan |
Condition
Condition
Arrhythmia
Classification by specialty
| Medicine in general | Blood transfusion | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In apheresis donors (>40 years old), we will examine the pulse wave to detect asymptomatic arrhythmia cases by fingertip pulse oximeter. We expect the safer effect for apheresis donors by this noninvasive and easy screening device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction of donation adverse cases
Key secondary outcomes
Detection of asymptomatic arrhythmia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Additional electrocardiogram examination
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Apheresis donors
Key exclusion criteria
Subjects who are deferred by pre-donation examination
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Sawamura |
Organization
Japanese Red Cross Tokyo Metropolitan Blood Center
Division name
Department of Medicine
Zip code
162-8639
Address
12-2, Wakamatsu-cho, Shinjuku-ku, Tokyo
TEL
0352723532
y-sawamura@ktks.bbc.jrc.or.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Sawamura |
Organization
Japanese Red Cross Tokyo Metropolitan Blood Center
Division name
Department of Medicine
Zip code
162-8639
Address
12-2, Wakamatsu-cho, Shinjuku-ku, Tokyo
TEL
0352723532
Homepage URL
y-sawamura@ktks.bbc.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Tokyo Metropolitan Blood Center
Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Society
Blood Service Headquarter
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Society Blood Service Headquater Central Blood Institute
Address
2-1-67 Tatsumi Koto-ku Tokyo
Tel
0355347508
kenkyu1@jrc.or.jp
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
東京都赤十字血液センター（東京都）/Japanese Red Cross Tokyo Metropolitan Blood Center(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | 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
3549
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
| 2021 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Up to 2023/1/31, we studied 1,556 donors for monitoring. Our study is ongoing now.
Management information
Registered date
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053518
