UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019830 |
|---|---|
| Receipt number | R000022909 |
| 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 | 2015/11/25 |
| Last modified on | 2022/09/16 13:40:33 |
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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
TRANExamic acid in renal bioPSY study (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
TRANExamic acid in renal bioPSY study (TRANEPSY study)
Region
| Japan |
Condition
Condition
Pathological states in which percutaneous renal biopsy is indicated
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the use of tranexamic acid in percutaneous renal biopsy is effective in reducing bleeding, and to investigate its optimal dose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perirenal hematoma, measured by ultrasonography on the morning following the 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
High dose group (1,000mg): intravenous bolus injection of 500mg of tranexamic acid just before the biopsy, and drip infusion of 500mg of tranexamic acid with saline solution after the biopsy
Interventions/Control_2
Low dose group (500mg): intravenous bolus injection of 250mg of tranexamic acid just before the biopsy, and drip infusion of 250mg of tranexamic acid with saline solution after the biopsy
Interventions/Control_3
Control group: intravenous bolus injection of saline solution just before the biopsy, and drip infusion of saline solution after the biopsy
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
Adults aged 20 years or more who will undergo a percutaneous biopsy of their native kidney
Key exclusion criteria
- Those for whom amyloidosis is suspected
- Those for whom tranexamic acid is contraindicated
- Pregnant or breast-feeding women
- Those who need tranexamic acid for treatment
- Those who are judged to be unsuitable as research subjects by the investigators
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Matsuzaki |
Organization
Kyoto University
Division name
Department of Preventive Services, Kyoto University Graduate School of Public Health
Zip code
606-8501
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 | Junichi |
| Middle name | |
| Last name | Izawa |
Organization
Kyoto University
Division name
Department of Preventive Services, Kyoto University Graduate School of Public Health
Zip code
606-8501
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
Department of Preventive Services, Kyoto University School of Public Health
Address
Yoshida-konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4400
izawa.junichi.87r@st.kyoto-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
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 | 25 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36088901/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36088901/
Number of participants that the trial has enrolled
56
Results
We assessed 90 adult patients for study eligibility, of whom, 56 were randomly allocated into the three groups: 20 for high-dose tranexamic acid, 19 for low-dose tranexamic acid, and 17 for placebo. The median size of perirenal hematoma was 200 mm2 [interquartile range 21-650] in the high-dose tranexamic acid group, 52 mm2 [0-139] in the low-dose tranexamic acid group, and 0 mm2 [0-339] in the placebo group (p = 0.048 for high-dose tranexamic acid vs. placebo).
Results date posted
| 2022 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult patients with clinical indication for ultrasound-guided percutaneous biopsy of a native kidney
Participant flow
From January 2016 through July 2018, we assessed 90 consecutive patients aged 20 or older who needed ultrasound-guided percutaneous kidney biopsy of a native kidney. Of these, the 56 patients who met our eligibility criteria were randomly assigned into three groups: 20 patients were assigned to the high-dose tranexamic acid group (1000 mg), 19 were assigned to the low-dose tranexamic acid group (500 mg), and 17 were assigned to the placebo group.
Adverse events
None
Outcome measures
Post-biopsy perirenal hematoma size as measured by ultrasound on the morning after the biopsy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022909
