UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016940 |
|---|---|
| Receipt number | R000019663 |
| Scientific Title | Parameters of coagulation oriented DIC treatment |
| Date of disclosure of the study information | 2015/03/27 |
| Last modified on | 2018/09/28 11:23:30 |
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Basic information
Public title
Parameters of coagulation oriented DIC treatment
Acronym
Parameters of coagulation oriented DIC treatment
Scientific Title
Parameters of coagulation oriented DIC treatment
Scientific Title:Acronym
Parameters of coagulation oriented DIC treatment
Region
| Japan |
Condition
Condition
inflammatory DIC
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of DIC treatment using coagulation parameters
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Outcome, DIC free days
Key secondary outcomes
Use of drug for DIC treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard unticoagulant DIC treatment directed by JAAM DIC Score
Interventions/Control_2
Standard unticoagulant DIC treatment directed by ATIII activity and TAT level
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Systemic Inflammatory Response Syndrome
Key exclusion criteria
hemorrhagic disease, malignancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Oda |
Organization
Tokyo Medical University
Division name
Emergency and CCM
Zip code
Address
6-7-1, 1, Nishi-Shinjuku, Shinjuku, Tokyo, Japan
TEL
+81-3-3342-6111
odajun@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Oda |
Organization
Tokyo Medical University
Division name
Emergency and CCM
Zip code
Address
6-7-1, 1, Nishi-Shinjuku, Shinjuku, Tokyo, Japan
TEL
+81-3-3342-6111
Homepage URL
junoda@v001.vaio.ne.jp
Sponsor or person
Institute
Department of Emergency and CCM, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Internal funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2015 | Year | 03 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 27 | 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
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019663
