UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023916 |
|---|---|
| Receipt number | R000027410 |
| Scientific Title | Validation of the Bleeding Risk and Mortality in the Use of Warfarin and Antiplatelet Agents in Hemodialysis Patients |
| Date of disclosure of the study information | 2016/09/10 |
| Last modified on | 2020/03/15 13:27:22 |
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Basic information
Public title
Validation of the Bleeding Risk and Mortality in the Use of Warfarin and Antiplatelet Agents in Hemodialysis Patients
Acronym
Validation of the bleeding risk and mortality in hemodialysis patients
Scientific Title
Validation of the Bleeding Risk and Mortality in the Use of Warfarin and Antiplatelet Agents in Hemodialysis Patients
Scientific Title:Acronym
Validation of the bleeding risk and mortality in hemodialysis patients
Region
| Japan |
Condition
Condition
End stage renal failure on hemodialysis
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether warfarin therapy and antiplatelet medication influence bleeding and prognosis in hemodialysis patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding events during the follow-up period
Key secondary outcomes
All-cause death
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with end stage renal failure who underwent hemodialysis at baseline.
Key exclusion criteria
Patients who did not give informed consent, and who were lost to follow up due to a transfer to other institutions.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoriko Horiguchi |
Organization
Sagami Junkanki Clinic
Division name
Department of Internal Medicine
Zip code
Address
4-21-15, Sounan, Minami-ku, Sagamihara City, Kanagawa
TEL
0427462211
dzq04361@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoriko Horiguchi |
Organization
Sagami Junkanki Clinic
Division name
Department of Internal Medicine
Zip code
Address
4-21-15, Sounan, Minami-ku, Sagamihara City, Kanagawa
TEL
0427462211
Homepage URL
dzq04361@nifty.com
Sponsor or person
Institute
Sagami Junkanki Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027410
