UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034874 |
|---|---|
| Receipt number | R000039758 |
| Scientific Title | Development of technology for prediction of vasovagal reaction on blood donation by continuous monitoring using laser Doppler flowmetry |
| Date of disclosure of the study information | 2018/11/14 |
| Last modified on | 2020/05/11 11:05:42 |
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Basic information
Public title
Development of technology for prediction of vasovagal reaction on blood donation by continuous monitoring using laser Doppler flowmetry
Acronym
Developmental study on prediction of VVR using LDF
Scientific Title
Development of technology for prediction of vasovagal reaction on blood donation by continuous monitoring using laser Doppler flowmetry
Scientific Title:Acronym
Developmental study on prediction of VVR using LDF
Region
| Japan |
Condition
Condition
Vasovagal reaction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By introducing continuous monitoring using laser Doppler flowmetry (LDF), abnormal physiological changes are possibly detected at the begining of VVR on blood donation. Suitable interventional procedure which is initialized by LDF information supposed to be effective to prevent severe reaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction of VVR cases
Key secondary outcomes
Development of preventive procedures for VVR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Device,equipment | Maneuver |
Interventions/Control_1
Arrangement of speed on extracorporeal circulation
Interventions/Control_2
Posture change of a donor (Flatting donor chair)
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
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Platelet apheresis donor
Key exclusion criteria
Subjects who are deferred by pre-donation examination
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Yamamoto |
Organization
Hokkaido Red Cross Blood Center
Division name
General Affairs
Zip code
063-0802
Address
2-1, Nijuyonken, Nishi-ku, Sapporo, Hokkaido
TEL
0116136121
y.tetsu@hokkaido.bc.jrc.or.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Yamamoto |
Organization
Hokkaido Red Cross Blood Center
Division name
General Affairs
Zip code
063-0802
Address
2-1, Nijuyonken, Nishi-ku, Sapporo, Hokkaido
TEL
0116136121
Homepage URL
y.tetsu@hokkaido.bc.jrc.or.jp
Sponsor or person
Institute
Hokkaido Red Cross Blood Center
Blood Collection
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
北海道赤十字血液センター（北海道）/Hokkaido Red Cross Blood Center(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3492&co_id=50542&s_id=1491&file=1
Publication of results
Partially published
Result
URL related to results and publications
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3492&s_id=1491&co_id=50686&file=0
Number of participants that the trial has enrolled
519
Results
Unpublished result
In the second series,204 subjects were studied, and 8 cases of VVR were observed. 6 of 8 cases were able to be analyzed without any abnormalities such as data interruption. In 4 VVR donors, the onset of VVR could be recognized by the alarm warning, and supposed to be succeeded in eraly detection. One of the other was assessed as VVR due to hypotention, although there were no symptoms.
Results date posted
| 2020 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039758
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
