UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019504 |
|---|---|
| Receipt number | R000022545 |
| Scientific Title | The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Single Center, Triple-blinded Randomized Controlled Trial |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2015/11/18 09:21:15 |
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Basic information
Public title
The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Single Center, Triple-blinded Randomized Controlled Trial
Acronym
TRANEPSY study
Scientific Title
The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Single Center, Triple-blinded Randomized Controlled Trial
Scientific Title:Acronym
TRANEPSY study
Region
| Japan |
Condition
Condition
Any conditions that are the indication of percutaneous renal biopsy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether tranexamic acid in percutaneous renal biopsy is effective to reduce bleeding and
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perirenal hematoma measured by using ultrasonography on the next morning after percutaneous renal biopsy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Higher dose of tranexamic acid (TA): 1,000mg
TA will be administered intravenously with the bolus dose of 500mg just before the renal biopsy, then administered intravenously with the continuous dose of 500mg in normal saline after the procedure.
Interventions/Control_2
Lower dose of tranexamic acid (TA): 500mg
TA will be administered intravenously with the bolus dose of 250mg just before the renal biopsy, then administered intravenously with the continuous dose of 250mg in normal saline after the procedure.
Interventions/Control_3
Normal saline (NS): Placebo
NS will be administered intravenously with the equivalent bolus dose just before the renal biopsy, then administered intravenously with the equivalent continuous dose in normal saline after the procedure.
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
Inclusion criteria will be adult patients who are aged 20 years or more, and who will undergo percutaneous biopsy of the native kidney.
Key exclusion criteria
Exclusion criteria will be patients who are suspected of amyloidosis, who have any contraindication of tranexamic acid, who are pregnant or breast-feeding, who need tranexamic acid for treatment or who are thought not to be suitable to participate in the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Matsuzaki |
Organization
Kyoto University
Division name
Department of Preventive Services, Kyoto University Graduate School of Public Health
Zip code
Address
Kyoto University Health Service, Yoshida-Honmachi, Sakyo-ku, Kyoto, Japan, 606-8501
TEL
075-753-2426
matsuzaki.keiichi.4v@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Izawa |
Organization
Kyoto University
Division name
Department of Preventive Services, Kyoto University Graduate School of Public Health
Zip code
Address
Kyoto University Health Service, Yoshida-Honmachi, Sakyo-ku, Kyoto, Japan, 606-8501
TEL
075-753-2426
Homepage URL
jizawa13@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okinawa Chubu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
沖縄県立中部病院 (沖縄県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2015 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022545
