UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Parameters of coagulation oriented DIC treatment
Title of the study (Brief title)	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	Jun Oda
Organization	Tokyo Medical University
Division name	Emergency and CCM
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	Jun Oda
Organization	Tokyo Medical University
Division name	Emergency and CCM
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019663