Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060643) titled 'Study on the immunological mechanisms of tranexamic acid induced anaphylaxis' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Nagoya University
Condition:
Condition - Tranexamic acid induced anaphylaxis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the immunological mechanisms of tranexamic acid induced anaphylaxis
Basic objectives2 - Others
Intervention:
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)
Eligibility:
Age-lower limit - 18
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 Size - 6
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068315
Disclaimer: Curated by HT Syndication.
