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 anaphylaxis 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

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 Maneuver
Interventions/Control_1	Skin test and flow cytometry will be performed once per subject. Drugs using for these tests will be different depending on cases.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The patient 15 years or older, who underwent general or spinal anesthesia or their next of kin 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	4

Research contact person
Name of lead principal investigator	Nagahide Yoshida
Organization	Saiseikai Maebshi Hospital
Division name	Department of Anesthesiology
Address	564-1 Kamisinden-machi, Maebashi, Gunma
TEL	027-252-6011
Email	totemkopf@hotmail.co.jp

Public contact
Name of contact person	Noriko Seki
Organization	Saiseikai Maebshi Hospital
Division name	Crinical Reserch Center
Address	564-1 Kamisinden-machi, Maebashi, Gunma
TEL	027-252-6011
Homepage URL
Email	totemkopf@hotmail.co.jp

Sponsor
Institute	Saiseikai Maebshi Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
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	2016 Year 03 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 26 Day
Anticipated trial start date	2016 Year 03 Month 29 Day
Last follow-up date	2017 Year 12 Month 10 Day
Date of closure to data entry	2017 Year 12 Month 10 Day
Date trial data considered complete	2017 Year 12 Month 10 Day
Date analysis concluded	2018 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 17 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024787