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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035759
Receipt No. R000040729
Scientific Title The study for seeking acceptable duration of time and temperature during transportation of blood samples for basophil activation tests
Date of disclosure of the study information 2019/02/04
Last modified on 2019/02/03

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Basic information
Public title The study for seeking acceptable duration of time and temperature during transportation of blood samples for basophil activation tests
Acronym The study for seeking acceptable conditions during transportation of blood samples for basophil activation tests
Scientific Title The study for seeking acceptable duration of time and temperature during transportation of blood samples for basophil activation tests
Scientific Title:Acronym The study for seeking acceptable conditions during transportation of blood samples for basophil activation tests
Region
Japan

Condition
Condition Anaphylaxis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Basophil activation test (BAT) is an in-vitro examination to identify causative drug of anaphylaxis. Since BAT requires flow cytometer, it has been performed only in limited facilities. It takes long time to transport blood samples in some cases. We will investigate the influence of a duration of time and a temperature during transportation of blood samples on the results of basophil activation tests.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of a duration of time and a temperature during transportation of blood samples on basophils activation rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Blood sampling from volunteers (about 15 ml)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Male and female over 20 years old
Key exclusion criteria A volunteer taking antihistamine agent, antidepressnat agent, or steroid
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomonori Takazawa
Organization Gunma University Hospital
Division name Intensive Care Unit
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan 371-8511
TEL 0272208698
Email takazawat@gunma-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shigeru Saito
Organization Gunma University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan 371-8511
TEL 0272208453
Homepage URL
Email shigerus@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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
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
2019 Year 02 Month 04 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
2018 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 03 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040729

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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