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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016940
Receipt No. 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

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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
Email 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
Email junoda@v001.vaio.ne.jp

Sponsor
Institute Department of Emergency and CCM, Tokyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019663

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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