臨床研究等提出・公開システム

Scientific Title	The study for identifying the culprit agents of in-hospital and out-of-hospital anaphylaxis
Public Title	The study for identifying the culprit agents of in-hospital and out-of-hospital anaphylaxis

Contact for Scientific Queries	Name	Takazawa Tomonori
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
	Telephone	+81-27-220-8454
	E-mail	takazawt@gunma-u.ac.jp
Contact for Public Queries	Name	Haraguchi Takashi
	Affiliation	Gunma University Graduate School of Medicine
	Address	3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
	Telephone	+81-27-220-8454
	E-mail	m2020020@gunma-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 23, 2021
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patients with Grade 2 or higher anaphylactic symptoms at Gunma University Hospital 2)Patients with Grade 2 or higher anaphylactic symptoms at another hospital and referred to our hospital
	Exclusion Criteria	1)Pregnant women or patients who may become pregnant 2)patients who the doctor deems inappropriate for participating in this study
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		anaphylaxis
Intervention(s)		Blood sampling immediately after anaphylaxis and after 24 hours,skin tests,basophil activation test
Health Condition(s) Keyword		anaphylaxis
Intervention(s) Keyword		skin tests,basophil activation test
Health Condition(s) Code		D000707
Intervention(s) Code		D015549,D012882
Primary Outcome(s)		Tryptase,skin tests,basophil activation test
Secondary Outcome(s)		IgE radioimmunosorbents test, IgE radioallergosorbent test

Primary Sponsor	Department of Anesthesiology Gunma University Graduate School of Medicine

Secondary Sponsor

Source of Monetary Support	KAKENHI, Japan Society for the Promotion of Science (JSPS)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 02, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 31, 2025	(this page)	Changes
1	Sept. 23, 2021	Detail

List of change history