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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023916
Receipt No. 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 2016/09/02

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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
Email 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
Email dzq04361@nifty.com

Sponsor
Institute Sagami Junkanki Clinic
Institute
Department

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
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 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 08 Day
Last follow-up date
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
2016 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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