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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044394
Receipt No. R000050714
Scientific Title Evaluation of the Usefulness of Basophil Activation Test in the Prevention of Intraoperative Anaphylaxis
Date of disclosure of the study information 2021/06/05
Last modified on 2021/06/01

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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