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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002705
Receipt No. R000003297
Scientific Title Randomized controlled trial: Combination therapy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Date of disclosure of the study information 2009/11/10
Last modified on 2009/11/03

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Basic information
Public title Randomized controlled trial: Combination therapy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Acronym Combination therapy of Antithrombin and Thrombomodulin
Scientific Title Randomized controlled trial: Combination therapy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Scientific Title:Acronym Combination therapy of Antithrombin and Thrombomodulin
Region
Japan

Condition
Condition Sepsis associated with disseminated intravascular coagulation (DIC)
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the combination efficacy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of DIC score, coagulation and fibrinolytic markers six days after thrombomodulin
Key secondary outcomes Twenty-eight day mortality

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Antithrombin III, Three days, 1500IU, one administration/day
Interventions/Control_2 Antithrombin III, Three days 1500IU, one administration/day;thorombomodulin, Six days, 380IU/Kg, one administration/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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)ACCP/SCCM-defined sepsis criteria, 2)Japanese Association for Acute Medicine-defined DIC criteria score > 4
Key exclusion criteria 1)< Fifteen years of age, 2)Hematopoetic malignancy, 3)Comcomitant treatment with cartinostatics or irradiation, 4)Liver cirrhosis classified as Child-Pugh C
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomotsugu Yasuda
Organization Kagoshima University Hospital
Division name Intensive Care Units
Zip code
Address 8-35-1 Sakuragaoka Kagoshima City
TEL 099-275-5649
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomotsugu Yasuda
Organization Kagoshima University Hospital
Division name Intensive Care Units
Zip code
Address 8-35-1 Sakuragaoka Kagoshima City
TEL 099-275-5649
Homepage URL
Email yasutomo@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Hospital Intensive Care Units
Institute
Department

Funding Source
Organization Kagoshima University Hospital
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
2009 Year 11 Month 10 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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 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
2009 Year 11 Month 03 Day
Last modified on
2009 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003297

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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