UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for determining the drug resposible for perioperative anaphylaxis by using skin test and flow cytometry
Title of the study (Brief title)	The study for determining the drug resposible for perioperative anaphylaxis
Region	Japan

Condition
Condition	Perioperative anaphylaxis
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identifying the drug responsible for perioperative anaphulaxis is important for preventing the recurrence of anaphylaxis. We are going to perform skin tests and flow cytometry in this study.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identifying the drug responsible for perioperative anaphylaxis
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	13 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The patient 13 years or older, who underwent general or spinal anesthesia 2) The patient with perioperative anaphylaxis 3) The patient whose consent has been obtained in writing with respect to participation in this study
Key exclusion criteria	1)The pregnant woman /The patient who has a possibility of pregnancy 2)The patient taking beta blocker 3)The patient taking steroid 4)The patient to whom a doctor judged inappropriate for participating in this study
Target sample size	8

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 Anesthesiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2014 Year 11 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 23 Day
Anticipated trial start date	2014 Year 04 Month 23 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	Identifying the drug responsible for perioperative anaphylaxis

Management information
Registered date	2014 Year 11 Month 25 Day
Last modified on	2016 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018293