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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020617
Receipt No. R000023798
Scientific Title Utility of rivaroxaban for chronic disseminated intravascular coagulation
Date of disclosure of the study information 2016/01/19
Last modified on 2016/01/25

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Basic information
Public title Utility of rivaroxaban for chronic disseminated intravascular coagulation
Acronym Utility of rivaroxaban for chronic DIC
Scientific Title Utility of rivaroxaban for chronic disseminated intravascular coagulation
Scientific Title:Acronym Utility of rivaroxaban for chronic DIC
Region
Japan

Condition
Condition chronic disseminated intravascular coagulation
Classification by specialty
Medicine in general Cardiology Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the utility of rivaroxaban for chronic disseminated intravascular coagulation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety of rivaroxaban in treatment for chronic DIC (bleeding and thrombotic symptoms are estimated at 2w, 1M, 3M, 6M, 12M, 2y, 3y, 4y and 5y)
Key secondary outcomes effectiveness of rivaroxaban in treatment for chronic DIC

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of rivaroxaban for chronuc DIC (10mg, once a day for 5 years)
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 1. Patients with DIC, diagnosed with diagnostic criteria of DIC of Japanese Ministry of Health and Welfare.
2. Patients over 20 years old at the time of obtaining informed consent.
3. Patients whose written consent has been obtained from the the patients or legal representative

Key exclusion criteria 1. Patients with a history or serious drug allergy.
2. Patients with severe renal failure.
3. The patient, who are at risk of promoting the bleeding by administration of rivaroxaban.
4. The patients, who are presumed to die soon even though DIC is improvred.
5. The patients, who are pregnant, likely to be pregnant or breast-feeding.
6. The patients, who are not judged suitable for study patients by investigators.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidesaku Asakura
Organization Kanazawa University School of Medicine.
Division name Department of Internal Medicine (III)
Zip code
Address 13-1, Takaramachi Kanazawa, 920-8641, JAPAN
TEL +81-76-265-2000
Email hasakura@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidesaku Asakura
Organization Kanazawa University School of Medicine.
Division name Department of Internal Medicine (III)
Zip code
Address 13-1, Takaramachi Kanazawa, 920-8641, JAPAN
TEL +81-76-265-2000
Homepage URL
Email hasakura@staff.kanazawa-u.ac.jp

Sponsor
Institute Hidesaku Asakura,
Kanazawa University School of Medicine.
Institute
Department

Funding Source
Organization Self funding
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 01 Month 19 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 Enrolling by invitation
Date of protocol fixation
2013 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 18 Day
Last modified on
2016 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023798

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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