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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032972
Receipt No. R000037593
Scientific Title Analysis of coagulation and fibrinolytic markers in DIC patients complicated by various underlying diseases
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/13

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Basic information
Public title Analysis of coagulation and fibrinolytic markers in DIC patients
complicated by various underlying diseases
Acronym Analysis of coagulation and fibrinolytic markers in DIC patients
complicated by various underlying diseases
Scientific Title Analysis of coagulation and fibrinolytic markers in DIC patients
complicated by various underlying diseases
Scientific Title:Acronym Analysis of coagulation and fibrinolytic markers in DIC patients
complicated by various underlying diseases
Region
Japan

Condition
Condition DIC
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 validation of newly developed DIC diagnostic criteria
Basic objectives2 Others
Basic objectives -Others Analyze the dynamics of coagulation markers in DIC patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival rate of DIC patients at day 28
Dynamics of coagulation markers
Rate of DIC withdrawal and duration between diagnosis and withdrawal from DIC
Type of DIC treatment and its duration
Type and severity of underlying disease
Overall survival
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who are admitted to the hospital to treat the anderlying disease and supposed to develop DIC should be recruited. PLT less than or equal to 12x103/uL, fibrinogen less than or equal to 150mg/dL, FDP grater than or equal to 10ug/mL, 16 years of age or older.
Key exclusion criteria None
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Ikezoe
Organization Fukushima Medical University
Division name Department of Hematology
Zip code
Address 1 Hikarigaoka Fukusima
TEL 024-547-1193
Email hemato@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Ikezoe
Organization Fukushima Medical University
Division name Department of Hematology
Zip code
Address 1 Hikarigaoka Fukusima
TEL 024-547-1193
Homepage URL
Email ikezoet@fmu.ac.jp

Sponsor
Institute Fukusima Medical University
Institute
Department

Funding Source
Organization The Japanese Society on Thrombosis and Hemostasis
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
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
2018 Year 06 Month 15 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
2017 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are planning to explore the roles of DAMPs in development of DIC.

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037593

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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