UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060643 |
|---|---|
| Receipt number | R000068315 |
| Scientific Title | Study on the immunological mechanisms of tranexamic acid induced anaphylaxis |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/10 13:23:15 |
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Basic information
Public title
Study on the immunological mechanisms of tranexamic acid induced anaphylaxis
Acronym
TXA allergy study
Scientific Title
Study on the immunological mechanisms of tranexamic acid induced anaphylaxis
Scientific Title:Acronym
Immunological analysis of tranexamic acid induced anaphylaxis
Region
| Japan |
Condition
Condition
Tranexamic acid induced anaphylaxis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the immunological mechanisms of tranexamic acid induced anaphylaxis
Basic objectives2
Others
Basic objectives -Others
Mechanism of action
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of immunological responses related to tranexamic acid
Key secondary outcomes
Differences in immunological reactivity between healthy subjects and patients with a history of anaphylaxis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Intradermal testing and blood sampling for immunological assessment (patient)
Interventions/Control_2
Intradermal testing and blood sampling for immunological assessment (healthy controls)
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
One patient with a confirmed diagnosis of tranexamic acid induced anaphylaxis.
Approximately five healthy individuals with prior exposure to tranexamic acid who did not experience any allergic reactions and who met the following criteria.
Not taking antihistamines or corticosteroids on a regular basis
No history of severe skin disease
Key exclusion criteria
None
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Akiyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-Ku, Nagoya
TEL
052-744-2340
akiyama.koichi.b3@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Amano |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-Ku, Nagoya
TEL
052-744-2340
Homepage URL
amano.yasuhiro.f1@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Medical and Pharmaceutical Sciences, Laboratory of Bioinformatics and Pharmaceutical Sciences, Teikyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-Ku, Nagoya
Tel
052-744-2111
iga-shinsa@t.mail.nagoya-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
名古屋大学医学部附属病院（愛知県）、帝京大学医療薬学講座 生命情報薬剤学研究室（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
| 2026 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068315
