UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study
Title of the study (Brief title)	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	Shigeru SAITO
Organization	Gunma University Hospital
Division name	Department of Anesthesiology
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	Tomonori TAKAZAWA
Organization	Gunma University Hospital
Division name	Department of Anesthiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019269