UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054760 |
|---|---|
| Receipt number | R000062448 |
| Scientific Title | Effective fluid intake for prevention of vasovagal reaction (VVR) |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/06/13 11:22:57 |
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Basic information
Public title
Effective fluid intake for prevention of vasovagal reaction (VVR)
Acronym
Effective fluid intake for prevention of vasovagal reaction (VVR)
Scientific Title
Effective fluid intake for prevention of vasovagal reaction (VVR)
Scientific Title:Acronym
Effective fluid intake for prevention of vasovagal reaction (VVR)
Region
| Japan |
Condition
Condition
vasovagal reaction
Classification by specialty
| Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The risk of falls exists for all VVRs that occur after leaving the blood collection bed, but there is still no globally established preventive measure.
Preliminary studies at the Japanese Red Cross Tokyo Metropolitan Blood Center have shown that fluid intake according to the time of activity on the day of blood donation (time from waking up to coming to the blood donation site) is important for preventing VVR after leaving the blood collection bed, so a quasi-randomized controlled trial will be conducted to investigate the effect of fluid intake on VVR prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VVR incidence after leaving blood collection bed
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
On the intervention day, it is recommended that fluid intake be calculated according to the time of activity on the day of blood donation obtained in the preliminary study, and that the deficient amount be consumed before blood donation.
Interventions/Control_2
Non-intervention days are handled as usual.
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
| 16 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Meet blood donation criteria
Key exclusion criteria
Failure to meet blood donation criteria
Target sample size
8217
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Nishitani |
Organization
Japanese Red Cross Saitama Blood Center
Division name
Business Promotion Department 2
Zip code
337-0003
Address
955-1 Fukasaku, Minuma-ku, Saitama
TEL
048-684-1511
y-nishitani.vy@ktks.bbc.jrc.or.jp
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Ishimaru |
Organization
Japanese Red Cross
Division name
Blood Service Headquarters
Zip code
105-0011
Address
1-2-1 Shibakoen, Minato-ku
TEL
03-3433-5317
Homepage URL
f-ishimaru@jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Blood Service Headquarters Central Blood Institute
Address
2-1-67 Tatsumi, Koto-ku
Tel
03-5534-7508
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
| 2024 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062448
