UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022930 |
|---|---|
| Receipt number | R000026427 |
| Scientific Title | The effect on bleeding complication occurred by hemostatic agents discontinuation in the percutaneous renal biopsy |
| Date of disclosure of the study information | 2016/06/28 |
| Last modified on | 2020/07/26 05:40:53 |
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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
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
kyahata@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026427
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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