UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Acronym	Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Scientific Title	Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Scientific Title:Acronym	Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Region	Japan

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

Objectives
Narrative objectives1	We are performing specific IgE antibody measurement in the patient with perioperative anaphylaxis and considering its diagnostic accuracy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The diagnostic accuracy of specific IgE antibody measurement in the patient with anaphylaxis
Key secondary outcomes

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

Eligibility
Age-lower limit	0 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	1)The patient with a history of perioperative anaphylaxis 2)The patient whose causative agent of anaphylaxis has been determined by "The study for determining the drug responsible for perioperative anaphylaxis by using skin test and flow cytometry" 3)The patient provided a written consent to participate in this study
Key exclusion criteria	1)The patient doctor judged inappropriate to participate in this study
Target sample size	10

Research contact person
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	027-220-8693
Email	takazawt@gunma-u.ac.jp

Public contact
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	027-220-8454
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	2017 Year 03 Month 06 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	Completed
Date of protocol fixation	2017 Year 02 Month 22 Day
Date of IRB	2017 Year 02 Month 22 Day
Anticipated trial start date	2017 Year 03 Month 06 Day
Last follow-up date	2022 Year 02 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Measurement of specific IgE antibody levels

Management information
Registered date	2017 Year 03 Month 05 Day
Last modified on	2022 Year 03 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030163