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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016761
Receipt No. R000019269
Scientific Title Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study
Date of disclosure of the study information 2015/03/10
Last modified on 2017/03/14

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Basic information
Public title Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study
Acronym Skin test and flow cytometry in healthy volunteers
Scientific Title Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study
Scientific Title:Acronym Skin test and flow cytometry in healthy volunteers
Region
Japan

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

Objectives
Narrative objectives1 Although skin test has been widely used for identifying causative drug of anaphylaxis, it has some disadvantages including a risk of recurrent anaphylaxis and pain. The purpose this study is to establish an ideal tool for determing causative drug of perioperative anaphylaxis. For this purpose, we will focus on basophil activate test (BAT) with flow cytometry as an alternative to skin test. We will seek the maximum concentration not to see pseudo-positive reaction in healthy volunteers.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Seeking the optimum concentration of drugs for skin test and BAT
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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Histamin as a positive control
Normal saline as a negative control
Suspected drugs including sugamamdex and cephazolin
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 1) A volunteer who is 20 years or older
2) Avolunteer whose written consent has been obtained regarding participation in this study
Key exclusion criteria 1)A pregnant woman /A patient who has a possibility of pregnancy
2)A volunteer taking beta blocker
3)A volunteer taking steroid
4)A volunteer with past history of perioperative anaphylaxis
5)A volunteer to whom a doctor judged inappropriate for participating in this study
Target sample size 30

Research contact person
Name of lead principal investigator
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 027-220-8454
Email shigerus@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori TAKAZAWA
Organization Gunma University Hospital
Division name Department of Anesthiology
Zip code
Address 3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL 027-220-8454
Homepage URL
Email takazawt@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital, Department of Anesthesiology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2015 Year 03 Month 10 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
2015 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To estimate the optimum concentration of the perioperative agent for a skin test and BAT

Management information
Registered date
2015 Year 03 Month 10 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019269

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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