UMIN-CTR Clinical Trial

Basic information
Public title	The effect on bleeding complication occurred by hemostatic agents discontinuation in the percutaneous renal biopsy
Acronym	Hemostatic agents discontinuation and bleeding complication
Scientific Title	The effect on bleeding complication occurred by hemostatic agents discontinuation in the percutaneous renal biopsy
Scientific Title:Acronym	Hemostatic agents discontinuation and bleeding complication
Region	Japan

Condition
Condition	kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Demonstrate no difference in the incidence of serious bleeding complication with or without Carbazochrome sodium sulfonate hydrate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hematoma size measured by abdominal computed tomographic scan in 4 or 5 days after the renal biopsy
Key secondary outcomes	change with hemoglobin concentration before the renal bio -psy and 4 hours later and 4 days or 5 days later presence or absence of macroscopic hematuria presence or absence of erythrocyte transfusion presence or absence of angiographic embolization presence or absence of surgical procedure presence or absence of death

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hemostatic agents discontinuation
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent percutaneous renal biopsy and underwent abdominal computed tomographic scan after renal biopsy
Key exclusion criteria	Patients who were punctured with bilateral kidney with sampling difficulty Patients who received erythrocyte transfusion before confirming hemoglobin concentration in four hours after renal biopsy
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kensei Yahata
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Nephrology
Zip code
Address	1-1 Fukakusa-mukaihata cho, Fushimi-ku, Kyoto
TEL	075-641-9161
Email	kyahata@kyotolan.hosp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Kensei Yahata
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Nephrology
Zip code
Address	1-1 Fukakusa-mukaihata cho, Fushimi-ku, Kyoto
TEL	075-641-9161
Homepage URL
Email	kyahata@kyotolan.hosp.go.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 06 Month 28 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	Main results already published
Date of protocol fixation	2016 Year 05 Month 31 Day
Date of IRB	2016 Year 05 Month 31 Day
Anticipated trial start date	2016 Year 06 Month 28 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2019 Year 02 Month 01 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 06 Month 28 Day
Last modified on	2020 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026427