UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044394 |
|---|---|
| Receipt number | 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 16:20:50 |
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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
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
anesth-ym.jp-1974@mws.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University Medical School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050714
