UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020617 |
|---|---|
| Receipt number | 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 11:30:55 |
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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
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
hasakura@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Hidesaku Asakura,
Kanazawa University School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
