UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of BD Vacutainer UltraTouch Push Button Blood Collection Set on Turn-Around Time (TAT) reduction
Title of the study (Brief title)	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	Yanagihara Katsunori
Organization	Nagasaki University
Division name	Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
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	Tomaru Takeshi
Organization	Nippon Becton Dickinson Company, Ltd.
Division name	Medical Affairs
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028159