UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the Usefulness of Basophil Activation Test in the Prevention of Intraoperative Anaphylaxis
Acronym	Evaluation of the Usefulness of Basophil Activation Test in the Prevention of Intraoperative Anaphylaxis
Scientific Title	Evaluation of the Usefulness of Basophil Activation Test in the Prevention of Intraoperative Anaphylaxis
Scientific Title:Acronym	Evaluation of the Usefulness of Basophil Activation Test in the Prevention of Intraoperative Anaphylaxis
Region	Japan

Condition
Condition	Anaphylaxis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The basophil activation test (BAT) has been the focus of recent research as a safe method to identify the causative agent of anaphylaxis. It is known that when immediate allergy occurs, basophils in the blood are activated, and surface antigens such as CD203c and CD63 appear. Using this reaction, the patient's blood is mixed with the suspect drug in vitro, and the percentage of activated basophils in the total basophils is measured by flow cytometer.In previous studies, it has been described as having a sensitivity of 77% to 98% and a specificity of 75% to 100%, but this has not been sufficiently verified and standardized. In particular, there are no studies that have evaluated the accuracy of BAT after a long period of time from the onset of anaphylaxis, and the usefulness of BAT for cases of suspected anaphylaxis in the past is not certain. We would like to evaluate the changes over time by conducting regular BAT tests for cases of anaphylaxis to drugs used during surgery at our hospital during this study period.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in the net percentage of activated basophils over time
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who have clinical symptoms of anaphylaxis at our hospital during the study period and have been diagnosed as anaphylactic based on histamine and tryptase levels and skin test results. 2. Patients who have received a full explanation of the purpose of the study in the consent document approved by the Ethical Review Committee, and have given their free written consent. 3. Patients who are able to have blood drawn at the time of the study
Key exclusion criteria	Those who believe that even a blood sample of 1ml will have a negative impact on their health.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name kaneyuki Middle name Last name kawamae
Organization	Yamagata University Medical School Hospital
Division name	Department of Anesthesia
Zip code	990-2331
Address	2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL	023-633-1122
Email	anesth-ym.jp-1974@mws.id.yamagata-u.ac.jp

Public contact
Name of contact person	1st name shun Middle name Last name nagashima
Organization	Yamagata University Medical School Hospital
Division name	Department of Anesthesia
Zip code	990-2331
Address	2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL	023-633-1122
Homepage URL
Email	anesth-ym.jp-1974@mws.id.yamagata-u.ac.jp

Sponsor
Institute	Yamagata University Medical School Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Yamagata University Medical School Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Support Division, Administrative Department, Yamagata University, Iida Campus
Address	2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel	023-628-5047
Email	ikekenkyu@jm.kj.yamagata-u.ac.jp

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	2021 Year 06 Month 05 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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date	2021 Year 05 Month 13 Day
Last follow-up date	2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Observational study:Patients who had anaphylactic symptoms during surgery will be followed up for a maximum of 5 years (5-10 times) by collecting information (1-4) from the medical record, taking additional 1 ml of blood during the main department blood test (e.g., outpatient), and performing a BAT test using the obtained blood. No control group will be prepared.1. Subject background:Gender, age, medical history, allergic history 2. Clinical symptoms:Symptoms related to cardiovascular system, respiratory system, skin system, and severity of symptoms.3. Anesthesia information:Causative drugs (including those administered by the anesthesiologist during surgery, antimicrobial agents, etc.), treatment administered, and outcome.4. Laboratory results:Histamine, tryptase levels (post-episode and baseline), skin test, IgE

Management information
Registered date	2021 Year 06 Month 01 Day
Last modified on	2021 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050714