UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032972
Receipt number 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 15:38:39

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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 or person

Institute

Fukusima Medical University

Institute

Department

Personal name



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

Value
https://center6.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