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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022909


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name