UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of anthithrombin III therapeutic effect by frequency of administration in sepsis-associated disseminated intravascular coagulation
Acronym	Evaluation of anthithrombin III therapeutic effect in sepsis
Scientific Title	Evaluation of anthithrombin III therapeutic effect by frequency of administration in sepsis-associated disseminated intravascular coagulation
Scientific Title:Acronym	Evaluation of anthithrombin III therapeutic effect in sepsis
Region	Japan

Condition
Condition	Sepsis-associated disseminated intravascular coagulation
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate administration frequency for anti-thrombin III in disseminated intravascular coagulation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The period of improving DIC.
Key secondary outcomes	Improvment of coagurative and inflammatory marker

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1500U of AT was administered to the patients once a day
Interventions/Control_2	500U of AT was administered to the patients three times a day
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient of sepsis-associated disseminated intravascular coagulation which was indicated under 70% of AT III activity.
Key exclusion criteria	Age: under 20 years old Hematopoietic malignancy such as lykemia Patient under the anticoagulan treatment such as heparin or warfarin Liver cirrhosis (Child-Pugh score C) The patient will die within a few days regardless of treatment.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryu Yasuda
Organization	Gifu University Hospital
Division name	Advanced Critical Care Center
Zip code
Address	1-1 Yanagido, Gifu Japan
TEL	058-230-6448
Email	yasuryu@gifu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryu Yasuda
Organization	Gifu University Hospital
Division name	Advanced Critical Care Center
Zip code
Address	1-1 Yanagido, Gifu Japan
TEL	058-230-6448
Homepage URL
Email	yasuryu@gifu-u.ac.jp

Sponsor
Institute	Gifu University Hospital
Institute
Department

Funding Source
Organization	CSL Behring
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 06 Month 24 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	Terminated
Date of protocol fixation	2015 Year 06 Month 08 Day
Date of IRB	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 06 Month 15 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 24 Day
Last modified on	2019 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020585