UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034874
Receipt No. 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 2019/05/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Acceleration of venous return on lower limb
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
Email 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
Email y.tetsu@hokkaido.bc.jrc.or.jp

Sponsor
Institute Hokkaido Red Cross Blood Center
Blood Collection
Institute
Department

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
Email 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
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
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
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039758

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.