UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046902 |
|---|---|
| Receipt number | R000053494 |
| Scientific Title | A quasi-randomized controlled trial on prevention of delayed vasovagal reaction by salt intake at blood donation site. |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/02/16 12:27:04 |
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Basic information
Public title
Preventive effect of salt intake at blood donation site on vasovagal reaction.
Acronym
Preventive effect of salt intake at blood donation site on vasovagal reaction.
Scientific Title
A quasi-randomized controlled trial on prevention of delayed vasovagal reaction by salt intake at blood donation site.
Scientific Title:Acronym
A quasi-randomized controlled trial on prevention of delayed vasovagal reaction by salt intake at blood donation site.
Region
| Japan |
Condition
Condition
Vasovagal reaction
Classification by specialty
| Cardiology | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to determine if salt intake just before blood donation may prevent delayed vasovagal reaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of VVR in 3 different phase of blood donation. ( i.e. before needle removal, within 20 minutes after needle removal, and more than 20 minutes after needle removal.).
Key secondary outcomes
Comparison of incidence of VVR after adjustment by age, sex, estimated blood volume, and donation history.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Eat 3 candies containing salt (0.108g of salt per 1 candy) prior to blood donation.
Interventions/Control_2
Donate blood according to usual protocol.
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
| 17 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria: 1) person who is willing to donate blood and visiting blood donation site, and eligible for blood donation. 2) person who is willing to donate 400mL whole blood.
Key exclusion criteria
Exclusion criteria: Blood donors are excluded from this trial if 1) they are under salt restriction by their doctors, or 2) they are allergic for dairy products, or 3) their informed consent may not be obtained,
Target sample size
458252
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Namba |
Organization
Japanese Red Cross Tokyo Metropolitan Blood Center
Division name
Division of medical affairs
Zip code
162-8639
Address
12-2 Wakamatucho Sihjukuku Tokyo
TEL
0352723532
n-namba@ktks.bbc.jrc.or.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Namba |
Organization
Japanese Red Cross Tokyo Metropolitan Blood Center
Division name
Division of medical affairs
Zip code
162-8639
Address
12-2 Wakamatucho Sihjukuku Tokyo
TEL
0352723532
Homepage URL
https://www.bs.jrc.or.jp/ktks/tokyo/2021-028-20240331.pdf
n-namba@ktks.bbc.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Tokyo Metropolitan Blood Center
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
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
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 | 15 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053494
