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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024487
Receipt No. R000028159
Scientific Title Effectiveness of BD Vacutainer UltraTouch Push Button Blood Collection Set on Turn-Around Time (TAT) reduction
Date of disclosure of the study information 2016/10/24
Last modified on 2017/04/19

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Basic information
Public title Effectiveness of BD Vacutainer UltraTouch Push Button Blood Collection Set on Turn-Around Time (TAT) reduction
Acronym TAT reduction by BD UT PBBCS use
Scientific Title Effectiveness of BD Vacutainer UltraTouch Push Button Blood Collection Set on Turn-Around Time (TAT) reduction
Scientific Title:Acronym TAT reduction by BD UT PBBCS use
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the possibility that the use of BD UT PBBCS can reduce TAT for blood samples
Basic objectives2 Others
Basic objectives -Others To search the medichal technologist's impression about BD UT PBBCS use
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood collection time with BD UT PBBCS
Key secondary outcomes Impression about BD UT PBBCS use

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Medical technologists in the hospital laboratory
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yanagihara Katsunori
Organization Nagasaki University
Division name Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address Sakamoto 1-7-1, Nagasaki City, Nagasaki Prefecture, Japan
TEL 095-819-7200
Email k-yanagi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomaru Takeshi
Organization Nippon Becton Dickinson Company, Ltd.
Division name Medical Affairs
Zip code
Address Akasaka 4-15-1, Minato-ku, Tokyo
TEL 03-6234-5490
Homepage URL
Email takeshi_tomaru@bd.com

Sponsor
Institute Nippon Becton Dickinson Company, Ltd.
Institute
Department

Funding Source
Organization Nippon Becton Dickinson Company, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 24 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 Completed
Date of protocol fixation
2016 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 02 Month 17 Day
Date analysis concluded
2017 Year 02 Month 27 Day

Other
Other related information Simulation study using a model arm

Management information
Registered date
2016 Year 10 Month 19 Day
Last modified on
2017 Year 04 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028159

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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