UMIN-CTR Clinical Trial

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
Email	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
Email	jizawa13@gmail.com

Sponsor
Institute	Kyoto University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022909