UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027469 |
|---|---|
| Receipt number | R000031470 |
| Scientific Title | A pilot study investigating the effects of apixaban in patients with chronic disseminated intravascular coagulation (DIC) |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2022/06/01 18:38:48 |
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Basic information
Public title
A pilot study investigating the effects of apixaban in patients with chronic disseminated intravascular coagulation (DIC)
Acronym
Apixaban in chronic DIC
Scientific Title
A pilot study investigating the effects of apixaban in patients with chronic disseminated intravascular coagulation (DIC)
Scientific Title:Acronym
Apixaban in chronic DIC
Region
| Japan |
Condition
Condition
Chronic Disseminated Intravascular Coagulation(Chronic DIC)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to show that apixaban can improve the symptoms of DIC and DIC score, and be safe for patients with chronic DIC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of DIC score
Key secondary outcomes
Adverse event with apixaban (bleeding etc)
Drug compliance
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
Apixaban is administered
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 a diagnosis of DIC on the basis of criteria established by the DIC research group of the Ministry of Health and Welfare of Japan (1988 Revision)
2 Patients with any symptom by DIC
Key exclusion criteria
1 Patients with a history or present illness of severe allergy to a drug
2 Patients with severe renal disorder (< CLcr 30mL/min)
3 Patients whom the study drug might induce to bleed
4 Patients believed to die early even if they recovered from DIC, making it difficult to ensure a sufficient period of administration of the study drug and to obtain data on the efficacy and safety
5 Pregnant women, nursing mothers or possibly pregnant women
6 Patients whom the investigator considers to be unsuitable for participation in the study
7 Patients with severe hepatic disorder (< CLcr 30mL/min)
8 Patients with administration of other anticoagulants
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Nakayama |
Organization
Aichi Medical University Hospital
Division name
Division of Hematology
Zip code
Address
1, 1, Karimata, Yazako, Nagakute, Aichi
TEL
0561-62-3311
tnaka@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shohei Mizuno |
Organization
Aichi Medical University Hospital
Division name
Division of Hematology
Zip code
Address
1, 1, Karimata, Yazako, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
shohei@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University Hospital
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
| 2017 | Year | 05 | Month | 23 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031470
