UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049063 |
|---|---|
| Receipt number | R000055899 |
| Scientific Title | Pharmacokinetics of Tranexamic Acid |
| Date of disclosure of the study information | 2022/09/29 |
| Last modified on | 2024/12/24 13:01:09 |
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Basic information
Public title
Pharmacokinetics of Tranexamic Acid
Acronym
Pharmacokinetics of Tranexamic Acid
Scientific Title
Pharmacokinetics of Tranexamic Acid
Scientific Title:Acronym
Pharmacokinetics of Tranexamic Acid
Region
| Japan |
Condition
Condition
cardiac surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood levels in patients taking TXA to clarify the relationship between treatment effects and adverse reactions.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume of distribution, clearance and lowest blood concentration, blood loss, transfusion requirement
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cardiac surgery with CPB
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Tamura |
Organization
Nagoya Universuty
Division name
Anesthesiology
Zip code
466-8550
Address
Tsurumai-65, Showa-ku, Nagoya, 4668550, Japan
TEL
0527412111
takahiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Tamura |
Organization
Nagoya University
Division name
Anesthesiology
Zip code
466-8550
Address
Tsurumai-65, Showa-ku, Nagoya, 4668550, Japan
TEL
0527412111
Homepage URL
takahiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Univeristy
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
Tsurumai-cho 65, Showa-ku
Tel
0527412111
takahiro@med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 29 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055899
